New Product Development Engineer (Project Management)

We will be looking at both entry-level and experienced candidates for this position.
The NPD Product Development Engineer is responsible for developing, designing, testing, and inspecting new products while adhering to all regulatory and company requirements as applicable.

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.
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. ECOs (Engineering DCRs) 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.

New Product Development Specific Duties
1. Ability to perform process and equipment validations and complete the appropriate validation reports.
2. Investigate design factors such as ease of manufacture, availability of materials and equipment, interchangeability, cost, etc.
3. Create Production Work Instruction books /Assembly Drawings.
4. Create BOMs, routings, and pricing in company software systems (NetSuite).
5. Coordinating with vendors to source /quoting for new components.

LI
#LI

LI

LI