Senior Engineering Manager Systems and V&V
This role will report to the Emergency Care R&D Leader in Pune, India.
Your role:
- Working closely with the R&D Leadership team and the EC Leadership team to deliver quality, drive growth, and increase customer satisfaction.
- Actively promoting collaboration between R&D, PMO, Usability, Post-Market Surveillance, Regulatory, and Quality to optimize product safety, quality, and customer experience.
- Maintaining an environment of high expectations and accountability while driving functional excellence across all engineering teams. Must engage early in program planning and throughout the development process through to design transfer and operations.
- Ensuring an engaged, innovative, and inspiring working environment is maintained by motivating, challenging, and coaching for personal growth, entrepreneurship, and customer engagement. Drives high participation of internal quarterly engagement surveys.
- Driving design assurance prior to qualification phase by participating in early activities involving DFMEA, Design Reviews, and Safety Risk Management to ensure high confidence is present prior to the qualification phase.
- Developing and implementing suitable business transformation strategies to respond to customer needs, challenge existing system engineering practices, and identify new and better ways of working in order to accelerate Philips ECR towards achieving its strategic outcomes and increasing quality at every phase of the design and development lifecycle.
- Ensuring appropriate personnel management practices are in place regarding recruitment and selection, staffing and succession, remuneration, employee development, education and training, and management policy.
- Maintaining and improving existing design controls, product verification processes and work instructions.
- Working across global borders, cooperating with other leaders, peers, programs, and related business units and groups. Establishes a network with worldwide thought leaders, relevant players outside of the department and with the business and actively leverages this network for incorporating best practices.
- Always acting with the highest standards of integrity.
You're the right fit if:
- The successful candidate will have Bachelor’s Degree in Electrical / Mechanical Engineering or related field.
- Minimum 12+years of related management and technical management experience in the medical device or other similar industry.
- Demonstrated track record of building and driving high performance teams for results to commitments in medical device development in a highly regulated environment.
- Extensive knowledge/experience in the design of therapeutic medical device development. AED experience is a plus.
- Demonstrated knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC 60601-1-1 (CE mark), ISO 13485, and risk management requirements and development dependencies.
- Solid understanding of medical device product development, preferably Design Control experience with Class III medical devices. (FDA CFR Title 21, 820.30)
- Proven ability to lead and thrive in the matrix management structure.
- Demonstrates strong results orientation: This position requires the proven ability to consistently meet and/or exceed goals. The successful candidate must be capable of making commitments, setting priorities, and delivering results on time and on budget.
- Possess strategic agility/vision: Sees ahead clearly; can anticipate future concerns.
- Develops and maintains effective relationships and is capable of quickly earning trust and respect.
- Demonstrated record of decisiveness – an ability to act thoughtfully – and quickly.
- Strong overall business and interpersonal skills. Demonstrated experience in building, managing, and leading high-performing product development teams.
- Experience in performance management, team engagement, maintains a culture of accountability, integrity, and leads by example.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .