What are the responsibilities and job description for the Engineer I - Product Development position at Altimate Medical Inc?
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.