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Akkodis · 1 day ago

Medical Device Development Engineers

United States

Contract

Remote

Mid Level

$40/hr - $50/hr

3+ years exp

Akkodis is seeking Medical Device Development Engineers for a large remote 18 month project. The role involves managing post market activities of existing Design History Files for Medical Devices and requires excellent communication, teamwork, and organizational skills.

Information Technology & Services

H1B Sponsor Likely

Responsibilities

Author and Review existing Design History Files, identify scope, and mark gaps where necessary documents are missing

Utilize Vault Systems to manage Document workflow

Generate or analyze and update existing risk documentation (DFMEA or risk tables)

Coordinate, prepare, and conduct design reviews with cross-functional teams

Perform functional relationship analyses (FRA) and tolerance stack-ups

Generate comprehensive protocols to test/analyze the product for design verification and design validation (V&V)

Update prints and other design and manufacturing elements

Qualification

Biomedical EngineeringMedical Device ExperienceDHF DocumentationGD&TMicrosoft Office SuiteSolidWorksTechnical WritingOral PresentationsTeamworkOrganizational Skills

Required

B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent, and three to five years of medical device experience

Excellent communication, teamwork, and organizational skills

Self-starters and self-motivators

Author and Review existing Design History Files, identify scope, and mark gaps where necessary documents are missing

Utilize Vault Systems to manage Document workflow

Generate or analyze and update existing risk documentation (DFMEA or risk tables)

Coordinate, prepare, and conduct design reviews with cross-functional teams

Perform functional relationship analyses (FRA) and tolerance stack-ups

Generate comprehensive protocols to test/analyze the product for design verification and design validation (V&V)

Update prints and other design and manufacturing elements

Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)

Strong Background in DHF documentation authoring and executing for Medical Devices

Ability to effectively work within a team to expedite completion of critical project tasks with cross functional groups including Regulatory and Quality

Establishing a process method which meets performance and quality requirements

Ability to give clear and concise oral presentations

Technical writing

Microsoft Office Suite and SolidWorks proficiency

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

Glassdoor3.3

Akkodis provides digital engineering solutions for sustainable and innovative industries.

Zug, Zug, CHE

10001+ employees

https://www.akkodis.com

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)