System Designer

Akkodis is seeking Systems Designer for 100% Remote Role

Job Title: Systems Designer

Location: 100% Remote Role

Pay Range: $35/hr - 40/hr on W2 (The pay range may be negotiable based on experience, education, geographic location, and other factors)

Role : Contract

Job Description:

The ideal candidate will have a solid background in medical device design controls and product development, with direct experience in regulatory compliance and documentation. Youll play a key role in refining existing documentation and ensuring continued regulatory alignment to support new and existing products.

Candidates must have experience with software as a medical device (SaMD).

Requirements

• 5 years of experience

• Strong Experience with Software as a Medical Device (SaMD)

• Strong experience in design controls in a multi-disciplinary organization.

• Experience drafting and maintaining DHF (design history file) content, including user needs, design inputs, design outputs, traceability matrices, and risk documentation.

• Able to support risk analysis (e.g. uFMEA, etc.) and contribute to usability planning and design mitigations.

• Familiarity with ISO 14971 is required, and IEC 62366 preferred.

• Ability to define testable requirements, support V&V protocol development, and ensure traceability in collaboration with the Product Development team.

• Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders.

• Must have experience in a regulatory environment with strict compliance.

• Strong analytical skills and accurate judgment-making skills.

• Ability to deal effectively with internal and external collaborators.

• Excellent communications skills; written and verbal.

• Experience with Codebeamer, Jira, or similar.

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

· San Francisco Fair Chance Ordinance

Puneet Rajput

Resource Development Manager

T 1 610-206-0800

E puneet.rajput@akkodisgroup.com

Akkodis is a commercial brand under which both AKKA & Modis entities operate.

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