Senior Engineering Manager

1 Month ago • 15 Years + • Software Development & Engineering

Job Summary

Job Description

The Senior Engineering Manager will lead the R&D X-ray Image Chain team, overseeing Detectors, Grids, Collimators, Tubes, and Generators, and manage Norm Compliance Officers. This dual role involves technical leadership, ensuring successful development and compliance of diagnostic X-ray systems. Responsibilities include leading and mentoring the Image Chain components team, overseeing pre-development, product introductions, and lifecycle management. They will also coordinate technical investigations, ensure product quality, collaborate on software development, review product requirements, oversee compliance test plans, support certification documentation, manage regulatory submissions, maintain DXR compliance lab qualifications, and train teams on regulatory standards. The role demands experience in R&D, engineering, medical device design, and regulatory compliance.
Must have:
  • Minimum 15 years in R&D and engineering roles.
  • 3+ years of people management experience.
  • Medical device design and development experience.
Good to have:
  • System Engineering experience with Image Chain/Acquisition.
  • Experience with product safety and compliance.
  • Proficiency in regulatory submissions and compliance standards.

Job Details

Job Title

Senior Engineering Manager

Job Description

Senior Engineering Manager

Experienced Senior Engineering Manager to lead our R&D X-ray Image Chain (Detectors, Grids, Collimator, Tubes and Generators etc.) team and oversee our Norm Compliance Officers. This dual role requires a blend of technical acumen and people leadership to ensure the successful development and compliance of our diagnostic X-ray systems.

Job Responsibility:

  Engineering Management

  • Lead and mentor the R&D Image Chain Components (flat panel X-ray detectors, anti-scatter grids, generators, collimators and tubes)

  • Oversee pre-development, product introductions, and lifecycle management of Image Chain Components.

  • Manage Image Chain components road mapping in collaboration with external suppliers & releases with an international, cross-functional team.

  • Coordinate technical investigations into customer complaints.

  • Supervise Image chain advanced development activities.

  • Ensure product quality through thorough tests and requirements engineering.

  • Collaborate on software development projects.

Norm Compliance Leadership

  • Review product requirements related to safety, EMC, and environmental standards like IEC, EN, and ISO.

  • Oversee compliance test plans, including standards such as IEC60601 series and ISO 10993.

  • Oversee risk assessment and mitigation for product safety.

  • Support usability and software teams in creating certification documentation.

  • Ensure third-party component compliance and liaise with certification agencies (like TUV/CSA).

  • Oversee technical file deliverables for MDD, MDR, RED, REACH, and RoHS regulations.

  • Support audits and regulatory submissions (FDA, Notified Body, INMETRO).

  • Maintain DXR compliance lab qualifications according to ISO17025.

  • Train and guide cross-functional teams on regulatory standards and compliance execution.

  • Stay updated on regulatory changes and timely closure of standards gap assessments.

Job Knowledge, Skills and Experience:

  • Educational Background:   BE, BTech, ME, or MTech degree, preferably in Biomedical, Electrical, Electronics, or Instrumentation.

Experience:  

  • Minimum 15 years in R&D and engineering roles, with 3 to 5 years in System Engineering (preferably in product safety and norm compliance)

  • Minimum 3 years of people management experience

Technical Skills:  

  • Medical device design and development experience in imaging modalities (like X-Ray, CT, MRI, Ultrasound)

  • System Engineering - preferred experience with Image Chain/Acquisition, product safety and compliance

  • Proficiency in regulatory submissions and relevant compliance standards (e.g., CE Marking, FDA, Health Canada).

  • Preferred experience in product design and managing compliance documentation.

  • Preferred familiarity with IEC62304, ISO14971, IEC60601 series and ISO 10993

Leadership Skills: 

  • Proven leadership and mentoring abilities.

  • Strong problem-solving and project management skills.

  • Excellent communication and stakeholder management capabilities.

  • Ability to train and develop team members on compliance and regulatory standards.

Personal Traits: 

  • Detail-oriented with high ethical standards.

  • Adaptability to regulatory changes and proactive learning approach.

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.


About Philips
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 our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

#LI-EU
#LI-Hybrid
 

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About The Company

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.Together, we deliver better care for more people because we believe that every human matters.

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