What are the responsibilities and job description for the Medical Device Systems Engineer V&V position at Katalyst CRO?
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
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.
- 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.