Medical Device Development Engineer I

Akkodis; Warsaw (IN); On-site; USD 89,000 - 111,000; Full time

Benefits offered by this job

Medical, dental, vision

401K plan

Paid leave

EAP program

Commuter benefits

Job summary

Akkodis is seeking an onsite Medical Device Development Engineer I for a 12-month contract in Warsaw, IN. You will play a key role in new product design, development and commercialization, while supporting market products and regulatory compliance.

The role involves cross-functional coordination, design verification/validation, and risk management to ensure quality and regulatory adherence in a fast-paced medical device environment.

Qualifications

• Requires a Bachelor of Science in an engineering discipline (ME or BME or similar) from ABET-accredited program.
• Experience with medical device product development and regulatory requirements.
• Familiarity with design controls, risk management and verification/validation activities.

Responsibilities

• Stay current with arthroplasty product regulations and standards.
• Identify user needs through engagement with surgeons and product users.
• Translate needs into design inputs meeting market needs and regulatory requirements.

Skills

Regulatory knowledge

Design controls

Risk management

Product development

Education

ABET-accredited B.S. in ME/BME

Job description

Akkodis is seeking an onsite Medical Device Development Engineer I for a 12-month contract job with a client in Warsaw, IN. You have a key support role with responsibility for new product design, development, and commercialization; and/or to maintain in the market innovative medical device products in order to further the Company’s mission and grow Company’s market leadership position.

Rate Range: $42.86/hour to $53.57/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Medical Device Development Engineer I job responsibilities include:

• Stays current with and understands relevant arthroplasty product intended use, clinical procedures, and related regulations and standards
• Identifies user needs through engagement with product users (often Orthopedic Surgeons) and observation of similar device usage
• Translates targeted user needs into design requirements/inputs which satisfy unmet market needs to achieve business goals while also complying with global regulatory requirements and recognized external industry standards
• Creates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design features
• Prepares and reviews information for invention disclosures and patents
• Initiates, provides instruction for and coordinates with support from Company cross-functional team members in the production and inspection of product prototypes for preliminary evaluation; and final design verification, design validation and process validation
• Creates product production specifications which appropriately account for design for manufacturability (process capability) and inspection
• Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself to ensure appropriate quality control inspection plans are generated
• Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance with Company procedures and global regulatory requirements (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations)
• Authors, presents and obtains cross-functional team member approval of design control and risk management documentation as part of the product development process in compliance with Company procedures and global regulatory requirements
• Supports Company Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities

Desired Qualifications:

• Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.
• 1+ years of experience required.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers