Senior Device Lifecycle Engineer

About the role

The Senior Device Lifecycle Engineer supports the Device & Packaging Value Optimization Team within the Drug Product MSAT organization, which is a supply chain division of Johnson & Johnson Innovative Medicines. The role is based at the Schaffhausen, Switzerland or Beerse, Belgium manufacturing location. It covers the ongoing lifecycle engineering and technical support of combination products, moving from development to manufacturing and acting as the technical key point of contact for site operations and quality leadership.

Key responsibilities

• Scale up device manufacturing process capacity internally and externally, and develop and qualify additional supplier and sub-assembly capacity
• Handle device lifecycle engineering, including process and product engineering and support to the manufacturing network
• Act as subject matter expert on end-to-end medical device development and supply chain
• Support assembly sites in troubleshooting, review post-market vigilance data, and advise on CAPAs and mitigations
• Lead projects on customer satisfaction, quality, manufacturing improvements and cost reduction, and lead design change controls
• Perform technical assessments of combination product change controls and provide audit support
• Support continuous improvement, regulatory compliance and the technical community, and take part in cross-functional design and capacity change projects

Required profile

• Minimum of 9 years' experience in medical device design, development, new product introduction, manufacturing and/or technical support
• Bachelor's degree in Engineering or Science, preferably Mechanical, Biomedical or Materials
• Fluent native language (Flemish or German), bilingual in English, able to speak and present to customers, employees and regulators
• Experience complying with FDA CFR parts 3, 4, 210, 211 and 820, and with design control, change control, CAPA, complaints and ISO 13485
• Preferred: knowledge of plastics and metals processing, product/process design and validation (including Human Factors), statistical analysis, Six Sigma, and project management certification

Required skills

• Change control, CAPA, complaint handling, risk management tools, FMEA/FMECA
• Engineering drawing interpretation and process validation
• Root cause investigation, technical analysis and technical writing
• Ability to manage multiple priorities and products, and to communicate across levels of an organization

What we offer

• Base pay range of EUR 72,500 to EUR 115,230
• Annual bonus, vacation days, parental leave of at least 12 weeks, bereavement and caregiver leave, well-being reimbursement and insurance plans