Our client, a major Medical Device manufacturer that has been in business for almost 100 years, is located near White Plains NY, an area famed for it's high quality or life, and reasonable cost of living. With a location that's less an hour's drive from Times Square, the beach, and very rural farm country, all lifestyle desires are met here!
At this time, they are seeking a Senior Engineer, Product Software Quality who will
- be responsible for providing software process leadership that is influential and collaborative with new product development and software maintenance project teams
- support the on-time delivery of software development efforts that contribute to high quality, compliant, regulated devices available to the global market
- support the maintenance and improvement of the company’s software development processes.
- Provide strong software process leadership and guidance as a Quality member of technical teams supporting product development.
- Participate or lead on Software Peer Review teams, providing process guidance and software development expertise
- As part of stage-gate process, organize and preside over new and maintenance project design reviews
- Uses subject matter expertise in support of key technical reviews covering product Design, Development and Planning.
- Use methodologies including Agile, Lean, and Waterfall, to guide and assist project team members to deliver compliant, high quality device and application software
- more fun and impactful things!
- Bachelor's degree in: Computer Science, Software Engineering, or related field.
- 5+ years of experience in a software development environment, with technical software engineering experience (design, coding, testing).
- Experience with Software Quality and Risk Management standards including FDA 21 CFR 820, ISO 13485 IEC 62304 and ISO 14971.
- Proven ability/experience providing aspects of software process leadership and guidance as a member of technical teams.
- Experience with software development methodologies used for development of regulated devices.
- Experience with smart phones, smart devices and internet applications is preferred.
- Well-developed ability to exercise a broad range of effective communication skills - verbal, non-verbal, written, listening and negotiation.
- Software development or software engineering experience with medical or other regulated devices.