Senior Manufacturing Engineer (m/f/d)

Johnson & Johnson is currently seeking a Senior Manufacturing Engineer (m/f/d) to join our MedTech Surgery Team, located in Munich, Germany. At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

Job Summary:

As a Senior Manufacturing Engineer (m/f/d), you will play a central role in the success of the next generation of visualization products by bringing technical expertise and interpersonal skills to a sophisticated and fast-paced development team. In this role, you will help develop robust manufacturing processes and ensure the quality of the products Ethicon is developing.

Job Responsibilities:

1. Work with external partners to develop, qualify, validate, and stabilize component and equipment development process solutions for New Product Development (NPD) projects.
2. Apply engineering principles, world-class manufacturing techniques, statistical analysis, and judgment to resolve complex technical challenges, establish new methods, controls, and procedures.
3. Lead discussions between J&J R&D (Design & Development) and Contract Manufacturers (CM) and Suppliers to select and develop robust manufacturing process using Design for Manufacturing (DFM), Design for Assembly (DFA), Design to Cost (DTC), Design for Metrology tools and associated documentation including specifications, Build Protocols/Reports, Process Failure Mode and Effects Analysis (PFMEA), and Control Plan.
4. Act as the liaison between the J&J R&D teams and the CM in supporting the selection and bring-up of component/equipment suppliers.
5. Provide "voice of manufacturing" to influence design and include DFM/DFA feedback while maintaining Design Intent.
6. Lead efforts at suppliers to drive them for continuous improvement activities leading to yield and quality improvements using data driven approach and Lean Six Sigma methodologies, design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products.
7. Identify key process input variables and key process output variables.
8. Drive innovative product and process development that meets business commitments and stabilization metrics.

Qualifications and Experience:

Required:

1. Minimum B.S in Engineering (Mechanical, Electro-Mechanical, Opto-Mechanical, Biomedical Engineering or equivalent).
2. 4 years industry experience.
3. Engineering experience in electrical, electro-mechanical component, opto-mechanical, or electro-optical products and component development.
4. Experience in the areas of Design for Manufacturing or Assembly (DFM&A).
5. Experience working closely with external or third-party suppliers.
6. Experience working in a highly regulated industry (preferably medical device industry).
7. Knowledge and application of Geometric dimensioning and tolerancing (GD&T) (e.g., ASME Y14.5).
8. Measurement Systems Analysis experience (e.g., Gage Repeatability & Reproducibility (GR&R) and Process Capability Analysis).
9. Efficient in using statistical tools and six-sigma methodologies to help develop and stabilize manufacturing processes at suppliers.
10. Proven use and knowledge of Statistical Analysis tools (e.g., Design of Experiments (DOE), co-variability, Process Stability/Control/Capability).
11. Understand equipment concept creation, review approval, build, run off, Factory Acceptance Testing (FAT), software validation, and IQ, OQ, PQ road map requirements.
12. Proven interpersonal and communication skills, with the ability to work successfully in a cross-functional team environment.
13. Strong technical communication and documentation skills and proven ability to work independently.
14. Flexibility and ability to adjust to daily changes is essential.
15. Excellent verbal and written communications skills required in both English and German.

Other:

1. Willingness to travel up to 20% domestically (within Germany) and internationally (to United States).

Preferred:

1. Knowledge of FDA guidelines for the development of medical devices as well as international standards for medical device development such as IEC-60601, ISO-14971, and ISO-13485.
2. Knowledgeable about medical-specific assembly technologies, the equipment supplier base, and the capabilities of the suppliers.
3. Experience designing, developing, and testing the manufacturing of electro-mechanical equipment and systems.
4. Able to read and understand optical, electro-optical, mechanical, and electrical drawings and apply optical testing principles.
5. Experience designing, developing, and testing the manufacturing of electro-mechanical or opto-mechanical systems, including test and process development.
6. Knowledge in manufacturing processes such as polymer processing (molding, compounding, extrusion, fusing), metal processing (machining, laser cutting, polishing, welding), assembly, gluing, coating, equipment & tool design is preferred.
7. Certification in Six Sigma Process or Six Sigma Lean and knowledge of Statistical Analysis tools (e.g., Design of Experiments (DOE), co-variability, Process Stability/Control/Capability).
8. Proven knowledge of medical product design processes.
9. Test methods development (TMD) & Test methods validation (TMV) experience.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.

Additional information can be found through the link below. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. This position is classified as PG26, office based (incl. JnJ flex).