Medical Device Systems Engineer V&V

Summary:

As part of an R D project team, the Senior Systems and V&V Engineer provides technical contributions to system design and Verification/Validation of complex medical devices from concept through commercialization, or across the full product life cycle.

Roles & Responsibilities :

Defines customer needs and creates/modifies system requirements and architecture to meet them. Evaluates constraints, makes trade-off decisions, and contributes to module-level design requirements. Participates in product safety and security risk management activities, including DFMEA. Identifies technical risks and mitigations. Develops and executes verification and validation plans, protocols, scripts, regression, and reports. Collaborates closely with the Lead Engineer, Project Manager, and cross-functional teams to ensure project success. Provides guidance in design reviews and helps resolve technical issues. Focus on Systems and V&V Engineering for sustaining legacy products and/or new product development. Deliver all system and/or V&V engineering outputs with high quality. Generate alternatives and take reasonable risks when solving technical problems. Complete detailed, high-quality technical documentation to capture and communicate designs. Stay informed on business, market, and competitive environments. Use existing tools and best practices to report and track product and process metrics. Communicate proactively about developments or issues affecting work and commitments. Perform other duties as assigned. Education & Experience Bachelor's Degree in Engineering. 3+ years of relevant experience. Ability to generate alternative solutions for technical problems or processes. Strong interpersonal skills; works collaboratively in a team environment. Adaptable to change and demonstrates good judgment in selecting methods and techniques. Knowledge of medical device regulations and standards, including design control and risk management (preferred). Proficient with systems engineering tools such as DOORS, Polarion, and Minitab.

Familiarity with multiple systems areas:

electrical, mechanical, pneumatic, software, materials, and/or wireless connectivity. Strong technical writing and communication skills.