Manufacturing Engineer J&J Vision Uppsala
We are looking for a driven Manufacturing Engineer to lead process, equipment, and supplier-related improvement initiatives, ensuring robust, compliant, and efficient operations that support product quality and business growth. As Manufacturing Engineer, you will play a key role in maintaining, improving, and validating manufacturing processes and equipment. The role also includes working directly with suppliers on the tooling, equipment, and processes used to manufacture supplied materials and components. The Uppsala site is currently replacing end-of-life equipment with new equipment and, for the right person, this is a unique opportunity to contribute and grow with us on this exciting journey!
Key Responsibilities
•Serve as technical owner for assigned process areas and/or supplier-site tooling and equipment used to manufacture supplied materials and components, managing lifecycle activities such as upgrades, maintenance requirements, and obsolescence mitigation.
•Develop, maintain, and coordinate technical review of material and component specifications, translating product and manufacturing requirements into clear supplier requirements in collaboration with R&D and Quality.
•Work directly with suppliers to resolve material and component manufacturing issues, and assess proposed changes at the supplier against internal component specifications and quality requirements.
•Lead root cause investigations using structured problem-solving methodologies (5 Whys, Fishbone, 5M, etc) in alignment with J&J Non-conformity and CAPA processes.
•Plan and implement equipment and process validation activities in accordance with GMP, ISO 13485, and FDA 21 CFR Part 820 requirements, including Computerized System Validation where applicable.
•Collaborate cross-functionally with R&D, Quality, and Supply Chain to support technology transfer and automation initiatives and to ensure Design for Manufacturability and Assembly (DFMA).
•Foster a culture of innovation, safety, and continuous improvement across the manufacturing organization.
Qualifications
Education:
•BSc or MSc in Material Science, Mechanical, Electrical, Industrial, or related engineering field.
Experience and Skills:
•Minimum 2 years' experience in manufacturing or industrial engineering within a regulated industry (Medical Device or Pharmaceutical).
•Understanding of change control as well as equipment and process validation (URS, FAT, SAT, IQ, OQ, PQ, CSV).
•Experience developing or maintaining material and component specifications and translating technical requirements into supplier requirements.
•Experience working with suppliers on manufacturing processes, tooling, and equipment; knowledge of injection moulding is an advantage.
•Working knowledge of GMP, ISO 13485, and FDA 21 CFR Part 820 requirements.
•Analytical, structured, and proactive attitude with ability to handle multiple priorities.
•Fluency in English and Swedish.
Preferred Skills: Accelerating, Communication, Detail-Oriented, Execution Focus, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Science and Technology (MSAT), Problem Management, Project Engineering, Project Management Tools, Project Support, Report Writing, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy.
Pay and Benefits
The anticipated base pay range for this position is kr421,000.00 - kr678,500.00.
In addition to base pay, benefits include: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions. Vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. Service anniversary and recognition awards, and, subject to the terms of their respective plans, employees - and in some locations eligible dependents - can participate in several insurance plans.
