Senior Engineering Manager
Job Purpose:
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.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
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.
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• 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.
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