Principal Development Engineer

Overview:

Part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.

Responsibilities:

1. Summarizes and refines product specifications.
2. Brainstorms novel therapeutic concepts.
3. Performs concept refinement and generates detailed CAD design.
4. Prototypes and evaluates catheter-based designs.
5. Performs engineering calculations, including tolerance analysis.
6. Drafts complex drawings with a demonstrated understanding of component manufacturing methods.
7. Develops in-vitro test methods, including fixture design and fabrication.
8. Performs in-vivo and in-vitro study protocol development, execution, and reporting.
9. Develops manufacturing processes and documentation.
10. Creates and maintains designs controls documentation.
11. Generates product risk analyses.
12. Leads customer meetings. Communicates directly with clients in a timely and professional manner.
13. Participates in calls with prospective clients as a subject matter expert.
14. Authors multi-phase/PDP proposals and project timelines with little guidance.
15. Takes responsibility for the education and training of more junior engineers through the course of their own project work. May formally mentor one or more junior engineers. Fosters a culture of learning.
16. Exercises engineering leadership on internal and external meetings. Drives conversations towards desired goals and outcomes in a respectful and professional manner.
17. Presents and conveys complex engineering concepts to internal and external stakeholders. Uses situational awareness to optimize timeliness of communication and communication style.
18. Identifies and reports unmet customer needs applicable to Resonetics technology to the Advanced Technology Group.
19. Possesses broad experience with process development techniques used in the assembly of catheter-based devices. Troubleshoots and optimizes complex processes in an efficient and reliable manner.
20. Executes on broadly defined technical challenges/high level requests, defining specific direction for themselves and team members to achieve the desired outcome.
21. Displays creative problem-solving skills. Provides technical oversight to junior engineers and guides troubleshooting efforts.
22. Demonstrates deep technical expertise in specific technical and/or clinical areas.
23. Demonstrates superior productivity, independence, attention to detail, and self-motivation. Works unsupervised, exercising independent judgment within primary job functions.
24. Demonstrates an understanding of all technologies and facilities across Resonetics. Is able to identify and explain opportunities for vertical integration to junior engineers and to clients.
25. Maintains a growth mindset by actively seeking and accepting constructive feedback.
26. Demonstrates an ability to adapt quickly and positively to changing priorities and processes.
27. Demonstrates an understanding of the common inspection techniques used in medical device design and manufacturing. Incorporates Design for Metrology principles into their work.
28. Demonstrates an understanding of manufacturing priorities (efficiency, yield, line balancing). Routinely incorporates DFM and DFA principles when completing design tasks. Enforces an NPI mindset in interactions with junior colleagues.
29. Demonstrates familiarity and compliance with Quality SOPs. Has experience in all Product Development Process (PDP) phases sufficient to lead a project from Phase 0 through Phase 5.
30. Demonstrates strong time management and organizational skills. Employs organizational tools to optimize personal performance.
31. Demonstrates functional application of advanced Solidworks skills. Is able to coach junior engineers through complex modeling tasks. Drafts complex drawings with a demonstrated understanding of component manufacturing methods. Is proficient in GD&T.
32. Is able to successfully contribute to multiple projects concurrently. Assists junior team members with prioritization and time management.
33. Works with a clear sense of urgency and prioritizes a diverse workload.

Qualifications:

1. A minimum of 7 years experience in medical device product design and development.
2. Strong project management experience leading cross-functional teams in a technical environment.
3. Strong analytical and data-driven approach with proven problem-solving abilities.
4. Strong presentation, written, and verbal skills. Ability to communicate with all levels within the organization.
5. Solid team leadership, team building, and facilitation skills.
6. Demonstrated mediation skills and ability to resolve apparently conflicting requirements through effective communication.
7. Ability to facilitate a collaborative working environment for customers and team members.
8. Comfort communicating and/or presenting in front of clients and large project teams.
9. Ability and willingness to travel.
10. Close familiarity with FDA QSR and ISO 13485 medical device regulations.
11. Experience in all phases of the medical device product development lifecycle.

Compensation:

Pay Range: $125,000-145,000