Medical Device Development Engineer 3

Medical Device Development Engineer 3

Sunnyvale, CA      -  Hybrid

12+ Months (Possible Extension)

Job Description :

Primary Function of Position :

The individual in this role will leverage their expertise in Design controls to evaluate the impact of design changes on requirements, specifications, and risks.

The ideal candidate will be adept at producing technical documentation to meet the demands of software releases and regulatory submissions, thereby enhancing throughput and addressing trace gaps early in the development phase.

The successful candidate will possess both the technical acumen to comprehend software designs and a strong commitment to risk management and design control deliverables, ensuring the delivery of robust products to the market.

A sense of shared responsibility and reward, along with a dedication to high product quality, is essential for this role.

Roles and Responsibilities :

As a Software Design Control Engineer, you will be responsible for delivering technical documentation to support projects with minimal impact on resources while ensuring operational effectiveness.

You will work within the Multiport software team and collaborate closely with Design and Product Engineering, Quality, and Document Control teams.

Key responsibilities include :

Developing, executing, maintaining, and supporting Design Control Infrastructure (Risks / FMEAs, Requirements, etc.).

Generating trace reports, identifying, and resolving gaps through collaboration with various departments.

Informing design decisions based on documented product risk and design control strategy.

Supporting the Multiport team in creating trace, requirement, test protocol / report, TLTR, Known Anomaly List documents for regulatory submissions and software releases.

Experience / Skill / Job Requirements :

BS degree in engineering discipline, or equivalent

5+ years industry experience

Medical device experience

Familiarity with design controls risks, trace reports, design controls

Strong writing and grammar skills in areas of content development and writing style. Analytical ability to swiftly grasp and effectively communicate complex technical engineering concepts.

Preferred Qualifications and Skills :

Experience creating or modifying risks, trace reports, functional requirements, etc.

Knowledge of medical device regulations, both US and OUS (e.g., FDA regulations, MDR, China PTR, etc.).

Experience working with design control software (MKS, Polarion, etc.).