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Product Support Specialist 2021-16

Product Support Specialist 2021-16

Job Summary

The Technical/Customer Service Representative (TCSR) will work to ensure the highest standards in product delivery are met and are in accordance with customer requirements and manufacturing capabilities.  The TCSR will parther with cross-functional team members to drive product improvements based on end-user, therapist, and consumer feedback.  Supporting the CSR team in responding to customer product inquiries and satisfaction issues is key to this role.

Essential Functions


Technical Lead

  • Handles technical escalation calls for all product lines (Altimate Medical (“AMI”) and ActiveAid (“AA”)).
  • Tracks all issues obtained during technical calls/interactions and proactively raises awareness regarding issues before they become more problematic.
  • Documents, evaluates, analizes, and reviews information for learning and implementation opportunities for achieving the best results.
  • Evaluate and identifiess recurring product issues and partners with cross-functional team members in Quality, Product Development and Production to correct them.
  • Trains AMI and AA CS reps on recurring issues/problems and how to successfully address and stop reoccurances.
  • Partners with AMI/AA marketing team on video creation for training purposes.
  • Partners with Product Development and Quality by providing customer feedback on product improvement, and custom modifcation opportunities, issues and concerns.
  • Partners with Shipping and Quality to identify problems with particular models and packaging ideas to address concerns and issues

Customer Service Rep (AMI/AA)

  • Actively works as a Customer Service Rep, taking calls and supporting our customers through communication, service, hospitality, and information.
  • Works with Suppliers, HC professionals and consumers to fix mechanical issues with the product
  • Process inbound and outbound calls from all clients and suppliers in a timely manner and with a high standard of professionalism.
  • Handles customer correspondence, complaints and inquiries in a professional manner.
  • Identify, trouble shoot, research, and resolve customer issues.
  • Communicates with customers the status of orders, product availability, fulfillment, and shipping. 
  • Document any special handling requirements or instructions.
  • Data entry of customer product/parts orders.
  • Creation of accurate quotes and sales orders,
  • Enter all ship to addresses from M2M Sales Orders into Sales Force, links and dealers.
  • Create Sales Force history – keep Sales Force clean and updated.
  • Customer Complaints and Feedback.
    • Obtain and evaluate all relevant data to handle complaints and inquiries
    • Log all complaints/communications promptly
    • Immediately report any possible medical incident to Quality Management Representative
  • Assist Sales & Marketing with Owner’s Manuals, FAQs, trouble shooting, price lists, and assembly or instruction sheets
  • Attendance and participate in department and team meetings as needed
  • Satisfy requirements of Quality Management & Regulatory Compliance systems
    • Follow applicable policies and procedures
    • Complete records (as necessary)
    • Share ideas for process improvement
    • Assist with corrective & preventive actions and customer feedback/complaint reviews (as appropriate)
  •  Observe Safety Program provisions
    • Maintain clean and safe work area
    • Report potentially unsafe conditions
    • Use equipment and materials properly.

Minimum Requirements

  • Associates Degree+ preferred or equivalent experience in Customer Service and/or technical and/or troubleshooting role
  • 3+ Previous Customer Service experience (techincal experience preferred).  (Internal training on AMI/AA products will be provided as needed)
  • Sales Force experience a plus
  • Successful track record of partnering with cross-funcitonal departments, providing customer feedback and solutions
  • Sharing learning opportunities and how to’s with others
  • Mechanically inclined
  • Excellent telephone, verbal, written, and listening skills
  • Excellent customer service skills (understanding of AMI customer service philosophy and procedure)
  • Knowledge of modern office procedures and methods including telephone communications, office systems and record keeping
  • Microsoft office and basic computer skills/typing
  • Maintain Customer/company confidentialty
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Assembly Specialist

Assembly Specialist

Morton, MN, USA

Altimate Medical is dedicated to building quality products, safely and efficiently for our end-users.  We have an opening for an Assembly Specialist to join our fabulous team and support.  You will earn $14.00 per hour (minus taxes and withholdings).  There is also a $500 sign on bonus payable after 6 months of continuous employment.

SPECIFIC JOB DUTIES/RESPONSIBILITIES:

  • Coordinate Daily Plan with Production Mgr. and/or Assembly & Shipping Manager           
  • Assemble a quality product efficiently per internal training and work instructions/prints and perform continuous inspection per applicable inspection checklists
  • Follow quality procedures         
  • Notify Quality Assurance if any product or material is nonconforming
  • Notify Inventory Control of any inventory shortages
  • Maintain clean and safe work area
  • Occasionally jump in and support other departments based on business needs (i.e. assist with packaging/shipping)
  • Other duties as assigned

EDUCATION AND/OR EXPERIENCE:

  • HS Diploma or GED
  • Prior Assembly experience a plus
  • Thorough product knowledge (AMI will provide training)
  • Ability to follow prints
  • Knowledgeable on use of common hand tools
  • Knowledgeable on use of computers (AMI will provide additional internal training)
  • Physical Requirements: Ability to reach overhead, grip and work with tools, roll and transfer product from one location to another.  Push carts with varying weights that can exceed 100lbs.  Component Assemblies that can exceed 35lbs.

Interested?  Simply click on the “Apply” button and submit a resume or complete the online application. 

You can also drop off a resume or complete an application at:

262 W. 1st St.
Morton, MN 56270

No phone calls at this time

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Regulatory Compliance Manager, Req: 2021-01

Regulatory Compliance Manager, Req: 2021-01

Altimate Medical Inc. (AMHI) is looking for a Regulatory Compliance Manager.  This key position will maintain our Regulatory Compliance system.  The Regulatory System is integrated into the Quality Management System (QMS) to ensure the activities of AMHI conform to and are compliant with the Food & Drug Administration Regulations, Canadian Medical Device Regulations, European Medical Device Regulation, and other applicable regulations.

Location:  Altimate Medical is located in Morton, MN. Minnesota candidates in and around the area are encouraged to apply as travel to the Morton facility will be required from time to time. Applicants working and living near our MPI office in Kansas City, KS are also encouraged to apply and work from that location.

Specific Job Duties/Responsibilities:

  • Provide regulatory support for multiple Class I and Class II medical devices in US & global markets for the family of AMHI Companies. 
  • Ensure compliance with national and international regulatory requirements for existing and new medical devices.
  • Classify products per the applicable country’s regulations where the products will be marketed.
  • Prepare, review, and submit any applicable regulatory submissions.
  • Compile & review technical documentation per applicable requirements.
  • Review clinical literature and complete clinical evaluation reports on the medical devices per applicable requirements.
  • Prepare and maintain product listings and establishment registrations for US and Canada.
  • Prepare and provide the applicable documentation to obtain and/or maintain pre-determined international registrations per applicable requirements.  
  • Request Certificates to Foreign Government from the FDA as products are released to the market.
  • Support post-market surveillance activities.
  • Prepare & submit applicable regulatory reports as applicable. 
  • Evaluate proposed product changes for regulatory impact.
  • Interact with regulatory authorities and/or representatives/sponsors during any registration and/or submission/review process to ensure product approval as applicable.
  • Evaluate and interpret requests/direction provided by international representatives/sponsors to ensure proper alignment with requirements.
  • Review and approve product labeling and promotional materials to assure compliance with applicable regulatory requirements.
  • Manage GUDID coordination and labeler accounts for UDI compliance. 
  • Research and maintain current knowledge of changes to applicable laws, regulations, and industry standards.  Assist in the communication of this information to the appropriate individuals within the company.
  • Identify regulatory obstacles and emerging issues and work with other team members to develop solutions.
  • Assist Product Development in completion of checklists for applicable design & testing requirements.
  • Collaborate with Quality Manager/QMS Rep to assist with SOP development and updates (as applicable).
  • Participate in internal and external audits.
  • QST Member (Quality Steering Team)
    • Shares information regarding regulatory issues/developments.
    • Attend Management Review meetings
  • Other duties as assigned.

Education and/or Experience:

  • Bachelor’s Degree in scientific discipline or related field
  • Minimum 3+ years’ professional experience in regulatory affairs or in quality management systems related to medical devices.
  • Experience with FDA requirements, Canada Medical Device Regulations, European Union Medical Device Directive, and new EU MDR requirements required.
  • Experience with ISO 14971, ISO 13485, IEC 60601, and other quality standards preferred.
  • Experience working with cross-functional teams.
  • Experience working with technical documentation.
  • Ability to comprehend principles of engineering, human anatomy, and medical device use.
  • Ability to effectively manage multiple projects and priorities.
  • Strong organizational skills and time management skills
  • Excellent oral and written skills
  • Excellent analytical thinking skills
  • Proficient computer skills
  • Ability to travel up to 20% (domestic)

Authority:

  • Stop production if any process adversely affects product quality.
  • Have the authority to identify and evaluate quality issues in their position and to initiate, recommend and provide effective corrective actions to any quality problem.
  • Stop production if any process/condition poses a safety hazard.

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Sr. Human Resource Generalist

Sr. Human Resource Generalist

Altimate Medical Holdings Inc. (AMHI) has an exciting opportunity for a Sr. HR Generalist (“HRG”) to support its locations in Minnesota and Kansas City, KS as well as employees sitting throughout the USA.  AMHI is open to a remote employee in Minnesota with travel to Morton/Redwood Falls on a regular basis.  Due to being a manufacturing company, this position will be “onsite” for periods of time each month (adjusting for COVID or other restrictions).  The HRG will work with the VP of HR and support/take ownership of various HR activities across all sites/locations.  Key areas include recruiting, benefits administration, talent acquisition (posting, recruiting, interviewing, onboarding and offboarding), employee engagement, and other generalist activities.  The key to success in this position is the ability to build effective relationships with managers, business leaders and employees alike, and effectively implement and execute HR strategies, policies and programs.  Multitasking abilities and prioritizing activities is also key to this position. Driving retention, employee engagement and overall business value, the HRG will be a key member of our growing organization.

Responsibilities include but are not limited to:

  • Collaborate and execute talent management initiatives through partnership with Managers and Department heads, CEO/CFO
  • Develop and rollout internal initiatives and establish Talent Acquisition best practices; effectively planning and anticipating new arrivals before they “walk” through our doors through offboarding activities.
  • Partner with managers to effectively address and resolve day-to-day issues and concerns, giving HR guidance on recommended steps (knowing basic applicable employment laws)
  • Maintain a pulse and bring awareness surrounding employee engagement, retention concerns and opportunities
  • Utilize AMHI values to drive behaviors, rewarding and recognizing where appropriate to reinforce the company’s cultural goals and initiatives
  • Be actively seen and known by the employees as a trusted resource
  • Assist with open enrollment and readiness
  • Staying informed as to local market competitiveness related to programs, compensation, fringe benefits.
  • Supporting HR project work and/or cross-functional team activities as assigned or developed
  • Establish and maintain internal HR best practices (HR internal audit, set up and maintenance of personnel files, benefit folders, etc)
  • Other duties as assigned

Education and Experience

  • Bachelor’s degree in HR or business-related field.  Masters is a plus
  • 5+ years of Human Resource experience
  • 3+ years working in an operations or manufacturing environment (non-union).  Durable Medical equipment experience preferred but not required.
  • Demonstrated experience building successful relationships and instilling trust at all levels of the organization.
  • Ability to multi-task, provide critical thinking, conflict resolution and decision-making skills
  • Ability to work in an environment that requires strong deliverables. 
  • Strong interpersonal skills and collaborative nature
  • Proven multi-tasking capabilities, organizational and prioritization skills
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Powder Coater I

Powder Coater I

Morton-MN: ActiveAid (an AMHI company) is looking for a Powder Coater (PCI) to help us support the medial device community we serve.  You have the opportunity join a fantastic team at a starting wage of up to $17.00 per hour. Additionally, there is a $750 sign-on bonus (minus applicable taxes and withholdings) payable after 6 months of continual employment.

You will learn the three steps of powder coating in four key areas: Big Booth and oven, little booth and oven, wash tanks and loading dock.  Entry level PC’s will be provided with hands on training to successfully arrange parts in baskets for degreasing and final rinse.  PCs will be lifting parts from boxes/carts, pushing carts, using safety equipment and cleaning solutions, checking inventory and performing quality control checks.   In addition, duties will include inhouse sorting, hanging, painting, baking and delivery of finished products.  Keeping the paint area clean and free of debris is a must. 

Interested?  We would love to hear from you.  A

AMI offers a competitive benefit package.  Please apply online at https://altimatemedical.com/careers/ or stop by the office and complete an application.  No phone calls at this time, please. 

101 ActiveAid road,
Redwood Falls, MN 56283
Hours of Operation:  7:00am to -4:30pm, M-F

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Product Development Design Engineer 2021-12

Product Development Design Engineer 2021-12

Altimate Medical (AMI) is seeking a Product Development Design Engineer (“PDDE”) who is looking to join a small engineering team and partner with cross functional team-members to improve the lives of the customers we serve.  As a PDDE, you have the opportunity to make an incredible impact on the lives we touch with the products we make.  We are looking for a team-member who is interested in a long-term career path and willing to grow and learn.

We are a team who works closely to share ideas, brainstorm and come up with innovative ideas and solutions.  In order to do this, a key element of the position is the ability to take critical feedback from customers and work to understand, discern and formulate what the customer wants and/or needs.

AMI believes in what we are doing.  We strive to carry out our mission, vision and values in all we do and say each and every day.  Our customers matter and deserve only the best we can give.  Provided and when aligned with pandemic safety measures, this is an in-office position due to the face-to-face team synergy to get the development juices flowing.  Relocation assistance can be provided.  If quality and safety are an integral part of your design process, AMI may be the place for you. 

The PDDE must have a strong mechanical aptitude (i.e., curiosity of how things work, mechanisms, assemblies) with a strong penchant toward visual design, together with the ability to visually communicate ideas through CAD, graphic design, and manual arts.  The PDDE will need to “see” things before they are made reality and envision multiple components operating in layers of functionality, as well as grasp concepts applied to one design and incorporate them into different applications.”  As a PDDE, your contributions will be meaningful as you work toward a common goal, sharing your wealth of knowledge and experience with and gleaning information from, your where necessary.

 Essential Functions
  • Brainstorming and collaborating with team members and other departments on various design and problem-solving tasks related to new and existing products.
  • Developing high level conceptual ideas based on a framework of mechanical requirements.
  • Designing elements, components, and structures that will make up a product.  From the base frame to the upholstery accessories and everything in between.
  • Determining material selection, tolerances, finishes, etc.
  • Design work will include many different materials and many available processes, as well as exploring new methods to add to our repertoire.
  • Partner daily with a team of other professionals in a well-equipped office using Solidworks CAD platform, in-house 3D printing, and an extensively equipped in-house prototype shop.
  • Other duties as assigned.
Minimum Requirements
  • BSME, Industrial Design degree, or equivalent work experience considered.
  • 3+ years of active 3D CAD modeling experience. (Solidworks preferred). 
  • Simulation (FEA) proficiency or prior experience would be a plus.
  • Several years of equipment/consumer product design would be a plus.
  • Strength in Industrial Design is strongly preferred.  Design, elements, aesthetics, ergonomics, etc.
  • Proficiency in basic computer skills.  Word, Excel, etc.  Ability to learn various new software, design process system, etc.
  • Manual sketching and drawing skills are a plus.
  • Good understanding of Design for Manufacturability and Assembly or the ability to observe and understand various techniques used in our design applications and to further develop from there.
  • Good communication skills, verbal and written.  Must be able to articulate both actual and hypothetical complex ideas, well-rounded understanding of basic technical terms associated with design, engineering, manufacturing processes, and materials.
  • Aptitude for learning and retaining new information, skills, industry specific material, etc.
  • Team mentality, comfortable with taking direction and sharing ideas freely in a professional environment.
  • Proficient in internet research.  I.e., researching competitive product and organizing data into a meaningful format, spreadsheet, etc.
  • Potential for advancing into taking the lead position in a project or assignment and planning logical steps and tasks necessary to reach a goal with a pre-determined result within an allowable timeframe.  (Project coordination/management)
  • Organized, pays attention to detail, owns mistakes.
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Quality Control Specialist 2021-06

Quality Control Specialist 2021-06

Job Overview

Morton-MN: Altimate Medical is looking for a Quality Control Specialist to Assist with the maintenance of an established Quality Management System (QMS) which conforms to and is compliant with the Food & Drug Administration Quality System Regulation (FDA QSR), ISO 13485 Standard, and other applicable regulations/standards.

Primary responsibility is to assist the Quality Assurance Manager in conducting the final inspection of product.  Also, to assist the Quality team with calibration & equipment management, incoming receiving inspection, disposition of non-conforming materials, returns, parts validations, and other items.

Specific Job Duties/Responsibilities:

  • Documentation
    • Ensuring proper records are maintained appropriately to provide evidence of conformity to requirements.
  • Resource Management
    • Assist the Quality team to ensure appropriate Infrastructure exists and appropriate records are maintained, and that necessary Work Environment and Contamination Controls are in place to not adversely affect product quality.
  • Product Realization
    • Purchasing
      • Assist the Quality Assurance Manager in conducting verification of purchased product (receiving inspection) and maintain records.
      • Ensure proper identification (status labels) of incoming components
    • Production
      • Ensure that final product conforms to specification (complete, functions properly, labeled appropriately, etc.) and is clean by performing Final Inspection
    • Monitoring and Measuring Equipment
      • Assists Quality Assurance Manager, with calibration and maintenance activities.
  • Measurement, Analysis, and Improvement
    • Non-Conforming Product
      • Assist Quality Team with control of Nonconforming product.
    • Improvement
      • Identify, or assist in the identification/implementation of, process and QMS improvements.
  • Provide this support across AMHI business units as requested
  • Other duties as assigned.

Education and/or Experience:

  • High school education

Skills and Abilities:

  • Ability to follow procedures and apply to AMHI products and processes
  • Ability to read and follow product design prints
  • Detail oriented
  • Communication skills – oral and written
  • Flexible
  • Ability to trouble shoot and solve problems
  • Ability to work independently.
  • Ability to work individually and as part of a team
  • Ability to work with teams in multiple locations
  • Computer proficiency with Microsoft Office and ability to learn other software
  • Thorough product and process knowledge (internal training will be provided)
  • Knowledge on use of common hand/power tools and measuring devices
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Powder Coater I, Req: #2020-04/07

Powder Coater I, Req:  #2020-04/07

ActiveAid (an AMHI company) is looking for a Powder Coater (PCI) to help us support the medical device community we serve.  You have the opportunity join a fantastic team at a starting wage of $15.00 per hour.

You will learn the three steps of powder coating in four key areas: Big Booth and oven, little booth and oven, wash tanks and loading dock.  Entry level PC’s will be provided with hands on training to successfully arrange parts in baskets for degreasing and final rinse.  PCs will be lifting parts from boxes/carts, pushing carts, using safety equipment and cleaning solutions, checking inventory and performing quality control checks.   In addition, duties will include inhouse sorting, hanging, painting, baking and delivery of finished products.  Keeping the paint area clean and free of debris is a must. 

Interested?  We would love to hear from you.  Additionally, there is a $750 sign-on bonus (minus applicable taxes and withholdings) payable after 6 months of continual employment.

AMI offers a competitive benefit package. 

Please apply online:

Or stop by the office and complete an application.  No phone calls at this time, please. 

ActiveAid
101 ActiveAid Road
Redwood Falls, MN 56283
Hours of Operation:  7:00am to -4:30pm, M-F

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Powder Coater I

Powder Coater I

ActiveAid (an AMHI company) is looking for a Powder Coater (PCI) to help us support the medical device community we serve.  You have the opportunity join a fantastic team at a starting wage of $15.00 per hour. Interested?  We would love to hear from you.  Additionally, there is a $750 sign-on bonus (minus applicable taxes and withholdings) payable after working 6months of continual employment.

You will learn the three steps of powder coating in four key areas: Big Booth and oven, little booth and oven, wash tanks and loading dock.  Entry level PC’s will be provided with hands on training to successfully arrange parts in baskets for degreasing and final rinse.  PCs will be lifting parts from boxes/carts, pushing carts, using safety equipment and cleaning solutions, checking inventory and performing quality control checks.   In addition, duties will include inhouse sorting, hanging, painting, baking and delivery of finished products.  Keeping the paint area clean and free of debris is a must. 

AMI offers a competitive benefit package. 

Please apply online:

Or stop by the office and complete an application.  No phone calls at this time, please. 

ActiveAid
101 ActiveAid Road
Redwood Falls, MN 56283
Hours of Operation:  7:00am to -4:30pm, M-F