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MANIFEST Technology · 4 days ago

Senior Research And Development Engineer

Twin Cities Area

Contract

Onsite

Senior Level, Lead/Staff

$170K/yr - $175K/yr

10+ years exp

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. This role involves managing all stages of product development, ensuring products meet performance and quality standards, and leading cross-functional teams.

Information ServicesInformation TechnologyProject ManagementSoftware

No H1B

U.S. Citizen Only

Hiring Manager

David Slaymaker

Responsibilities

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

Qualification

Pulsed electric field (PEF)Medical device R&DMechanical design/CADISO 13485 complianceStatistical toolsMedical device materialsManufacturing methodsLeadership skillsCommunication skillsOrganizational skills

Required

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

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., SolidWorks) 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

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