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Product Development Engineer – Medical Devices jobs in United States
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Akkodis · 13 hours ago

Product Development Engineer – Medical Devices

Akkodis is seeking a Product Development Engineer – Medical Devices for a 12-month contract position. The role involves working with a team on the design of a new large bore delivery catheter and developing key deliverables for regulatory submissions.
Information Technology & Services
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H1B Sponsor Likelynote
Hiring Manager
Punit Pathak
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Responsibilities

Work with a small team of new product design engineers focused on the design of a new large bore delivery catheter
Works independently to develop key deliverables as part of a 510k regulatory submission. Deliverables include, but not limited to: CAD design, detailed print packages, specification generation and rationale, specification mapping to essential design outputs, DFMEAs, tolerance analysis, device material assessment(s), and bill of materials
Provides guidance to product and technology teams
Assesses the feasibility and soundness of alternative engineering processes, products, or equipment
Coordinates, manages, and documents project goals and progress and recommends appropriate revisions
Develop and coach others on engineering documentation
Demonstrates PDP/TPD system knowledge through coaching and delivery of high quality, high impact deliverables

Qualification

Medical Device ManufacturingDesign Controls510k Regulatory ExperienceTolerance AnalysisGD&TISO 13485ISO 14971Communication SkillsProblem SolvingTeam Collaboration

Required

Minimum of a bachelors degree in mechanical or biomedical engineering (or other related technical discipline)
5+ years of experience in design assurance, new product development or related medical device / regulated industry experience
Experienced in design controls, print packages, tolerance analysis, GD&T
Self-motivated with a passion for solving problems and a bias for action
Strong communication skills (verbal & written)
Demonstrated use of Quality tools/methodologies
Ability to effectively work and collaborate in a mixed onsite + remote environment
Demonstrated experience creating detailed technical documents

Preferred

Experience working with medical devices such as catheter or delivery systems
Quality Integration experience
510k regulatory experience
ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Experienced problem solver, capable of facilitating the problem-solving process
Adaptable and effective collaborator in a team environment or in self-directed work
Experience with design changes, complaint reduction, and corrective action

Benefits

Medical
Dental
Vision
Life insurance
Short-term disability
Additional voluntary benefits
An EAP program
Commuter benefits
401K plan
Paid Sick Leave
Holiday pay

Company

Akkodis provides digital engineering solutions for sustainable and innovative industries.

H1B Sponsorship

Akkodis has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (141)
2024 (121)
2023 (67)

Funding

Current Stage
Late Stage

Leadership Team

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Lane Greever
Chief Operating Officer (COO), Americas
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Kishore Raj
Vice President & Partner: Technology and Engineering Consulting and Services
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Company data provided by crunchbase