Product Development Engineer

We are hiring for Principal and Senior Engineer positions to support catheter-based product development, with an immediate need for a Principal Engineer who can serve as a technical lead on a program. This role will focus on catheter and single-use device design and development, ideally supporting both the technical execution and customer-facing aspects of the program in partnership with the PMO. Candidates should have a strong grasp of the NPI process (phases 0–5) and be capable of helping build a project team around this initiative. While we’re open to candidates at various levels, we’re especially interested in those from small to mid-sized companies who have seen multiple products through conception to commercialization. A background in mechanical engineering is preferred, though we welcome those with biomedical, electrical, or combination technology experience.

The ideal candidate will have hands-on catheter prototyping experience and a solid understanding of design controls, including crafting user inputs and building documentation such as DHF from templates. Familiarity with risk management, design assurance, and product development deliverables is essential.

Required Skills and Experience

• Hands-on catheter prototyping experience within the last 3 months
• Familiarity with design controls, including:

--Understanding and crafting user inputs

--Building documentation such as DHF from templates

• Strong understanding of the NPI process (phases 0–5)
• Experience supporting customer-facing programs and sharing responsibilities with PMs
• Background in small to mid-sized companies
• Proven track record of taking products from concept to commercialization
• Engineering degree (Mechanical preferred, but Biomedical, Electrical, or hybrid tech also considered)
• Comfortable moving into or going into a contract manufacturing organization

Nice to Have Skills and Experience

• Ability to support the PMO and customer interactions
• Experience in combination technology environments
• Comfortable crafting design control documentation collaboratively
• Strong communication and organizational skills
• Adaptable mindset and willingness to challenge inefficient processes
• Experience with product development deliverables
• Familiarity with risk management and design assurance practices