Senior Research And Development Engineer

Senior Research And Development Engineer

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This range is provided by MANIFEST Technology. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range: $/yr - $/yr

Helping candidates obtain great opportunities. Helping clients solve technical challenges with talented individuals.

PRINCIPAL R & D ENGINEER to Serve the Medical Device Industry

MANIFEST Technology is seeking a passionate and innovative Principal R&D Engineer to develop pulsed electric field (PEF) medical devices and lead innovative product design for our client. This role sets product specifications, manages all stages of product development—from research and design to manufacturing—and ensures products meet performance and quality standards. The engineer will lead cross‑functional teams and oversee design control activities aligned with the company’s quality system.

Position type:
Direct hire – Full time;
No C2C; US Citizen or Green Card holder only, please

Location:

Onsite in Minneapolis, MN area

Pay Range:
Salary $170K-$175K base pay;
Bonuses;
Benefits; W‑2;
No C2C

• Lead the design and development of Endogenex products.
• Define performance specifications and develop qualification plans for products.
• Lead the selection of product materials that meet customer, design, manufacturing and COGS requirements.
• Participate in process development activities that result in robust manufacturing processes that meet quality and manufacturability requirements.
• Lead the definition and development of test methods to ensure product meets specifications.
• Generate and release test protocols and reports.
• Lead and participate in animal and cadaver studies.
• Support biocompatibility, aging and distribution studies.
• Support regulatory filings and reviews.
• Perform system validations as required.
• Coordinate and supervise product/project scale‑up.
• Provide project status updates to all levels of the organization.
• Evaluate and procure the necessary equipment to manufacture medical device products.
• Oversee and conduct technical and statistical investigations concerning quality problems.
• Oversee the transition from design to development and development to manufacturing.
• Perform other related duties to benefit the mission of the organization.

• 4-year degree in a scientific or technical field, preferably mechanical or bio‑medical engineering. Ten+ (10) years’ experience in medical device research and development engineering.
• Experience with pulsed electric field (PEF) / pulse field ablation (PFA) products preferred.
• Excellent working knowledge of applicable external standards/regulations (ISO 13485, 21 CFR 820, IEC 60601, etc.). Success in developing products within a highly compliant quality system.
• Early‑stage medical device company experience.
• Excellent communication and leadership skills, with the ability to work effectively in a fast‑paced, collaborative environment.
• Proficiency in mechanical design/CAD (e.g., Solid Works) and statistical tools (e.g., Minitab, JMP).
• Proficiency in common medical device polymer and metallic materials.
• Proficiency in common medical device manufacturing and joining methods, including machining, extrusion, molding, soldering, bonding, potting and sealing.
• Proficiency with electrical test equipment and methods preferred, e.g. HiPot, continuity, resistance.
• Familiarity with GI anatomy and disease states preferred.
• Strong organizational, planning, and follow‑up skills and ability to hold self and others accountable.
• Strong proficiency with Microsoft Office tools including Word, Excel, PowerPoint, Teams, etc.

Mid‑Senior level

Full‑time (direct hire)

Information Technology and Engineering

Medical Equipment Manufacturing