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.