Engineer I - Product Development

JOB SUMMARY

The Product Development Engineer I (Beta to Launch) is responsible for bringing designs to production, including testing, verifying, and validating new products and options. This may include working with regulatory and testing facilities to ensure the products meet domestic and international medical device standards to obtain certification. They will work with supply chain to ensure production parts meet design requirements and ensure smooth transition to final production and assembly. Will also work with Design teams to ensure functionality of product meets standards and requirements.

ESSENTIAL FUNCTIONS

1. Responsible for technical inputs and regulatory inputs from statutory standard requirements (especially regarding safety).

2. Review and gather data from the following sources for design input:

a. Customer input, including complaints and customer feedback.

b. CAPA data.

c. Non-conforming product data.

d. Data on competing products.

e. Industry trends.

3. Follow AMHI stage/gate design process and perform tasks as required in the Design Control Software (Grand Ave).

4. Monitor design projects to ensure design deliverables are being completed as required.

5. Working knowledge of mechanical and visual design elements including strengths of materials, life cycle or durability calculations, visual design elements, aesthetics, ergonomics, etc.

6. Create conceptual designs as assigned and/or assist as needed.

7. Create prints to specification and maintain prints for clarity, completeness, conformance to standards and procedures, specs, and dimensions.

8. ECO’s (Engineering DCR’s) – initiate, monitor, and complete tasks necessary to close.

9. Design criteria for internal product testing regarding safe and effective use of the medical device, which includes writing test protocols and reports, testing and validation of designs.

10. Perform risk evaluation/update Risk Management files as required.

11. Collaborate with vendors to set & obtain specifications and on any quality/design issues.

12. Check completed layouts and drawings for clarity, completeness, conformity to standards, procedures, specifications, and dimensions.

13. Work with Beta to Launch team to bring protypes to market.

14. Responsible for maintaining the Item Master.

15. Support Marketing as needed with visual aid from CAD systems.

16. Observe Safety Program

a. Maintain a clean and safe work area.

b. Report potentially unsafe conditions.

c. Use equipment and materials properly.

d. Utilizes appropriate personal protective equipment where/when necessary.

17. Contributes to a respectful, non-hostile, non-violent work environment.

18. Understands the purpose, value, and impact work has on product customers and users.

19. Other duties as assigned.

Beta to Launch

20. Work with New Product Development Design team to bring products from protype to the market.

21. Ability to closely follow schedule, identify potential risks in the production process and develop mitigation plans.

22. Work with technical writer to complete stage gate deliverables as required.

23. Rework designs as assigned to ensure final product meets design intents.

24. Testing and validation of prototypes to ensure final parts meet standards and testing requirements.

25. Continuously evaluate and improve manufacturing processes for efficiency and quality.

26. Implement lean manufacturing principles when applicable.

27. Troubleshooting for technical issues and reworking designs with design team.

28. Update project documentation as required.

29. Investigate design factors such as ease of manufacture, availability of materials and equipment, interchangeability, cost, etc.

30. Check completed layouts and drawings for clarity, completeness, conformity to standards, procedures, specifications, and dimensions.

31. Be prepared to address unexpected challenges that may arise during production.

MISSION, VISION, VALUES

• Mission: Improving lives with thoughtfully designed medical technology.

• Vision: Lead in the design of innovative medical products, provide a superior customer experience, and maximize value and well-being for all our stakeholders.

• Values-

1. We Care: We believe in the power of the communities we create and serve. We care for the well-being of our team members and give back to the communities we live in. We impact lives and make a difference.

2. Passion Fuels our Success: We are driven to innovate and create a better quality of life for our customers. Listening to customers and understanding their needs is essential to developing winning solutions and our customer focus empowers us to deliver unique products.

3. Pride In What We Do: We take the time to do it right, deliver accurately and with the highest level of quality. We work together to solve complex problems, overcome challenges, and through collaboration, we multiply the power of our contributions. We want to be the best and teamwork allows us to win.

EDUCATION AND/OR EXPERIENCE

• Bachelor Degree in Mechanical Engineering or equivalent required with BS + 0-3 years experience preferred.

• Skills to use personal computer and various software packages (Excel, Word, Grand Ave, SolidWorks, 3D & FEA software, email, NetSuite, Microsoft project, Monday.com, etc.).

• Project management, communication/presentation, teamwork, result driven, problem solving, and analytical thinking skills.

• Strong 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.

• Ability to read and interpret prints.

• Self-starter, motivated, possess a creative and analytical thought process, growth minded; skills to organize/plan/prioritize work; ability to perform administrative activities; ability to contribute to building a positive team spirit.

• Strong attention to detail and organization.

• Ability to work independently with limited supervision.

• Apply feedback to improve performance.

• Solid understanding of Design for Manufacturability and Assembly Experience with equipment/consumer product design would be a plus.

• Mechanical aptitude and knowledge of materials, mechanisms, and various manufacturing processes is preferred.

PHYSICAL REQUIREMENTS & WORK ENVIRONMENT

• Lift up to 25 pounds.

• Ability to sit and use computer most of the workday.

• Must be willing to commute to Redwood Falls, MN office up to 50% of the time.

• Must be willing to travel to Kansas City, MO office up to 25% of the time.

• Ability to work from home when appropriate.

We offer a competitive base salary of $67,000 to $84,000 annually, based on experience and qualifications, along with annual bonus and profit-sharing opportunities tied to performance.

Beyond pay, our market-leading benefits are designed to support your wellbeing. These include medical, dental, vision, and life insurance, as well as short- and long-term disability coverage. We also provide a health savings account with company match, a retirement plan with employer contributions through Vanguard, and access to the Granite Assistance Fund for support when it’s needed most. We value time for rest and personal growth, offering generous paid time off, including volunteer time off and paid holidays.

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