As Senior Production Process Engineer, you will lead and support the development, optimization, and validation of manufacturing processes for Nordberg Medical’s implantable Class III medical devices. This role involves supporting scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced manufacturing techniques. You will play a crucial role in problem-solving and troubleshooting production issues while driving continuous improvement initiatives to enhance manufacturing capabilities while ensuring compliance with regulatory standards.
Key Responsibilities
Your responsibilities will include, but not be limited to:
Process Design and Development:
• Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device (Class III) products.
• Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and implement efficient, scalable, and compliant production processes.
• Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).
Process Validation and Qualification:
• Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes.
• Ensure validation protocols align with regulatory standards (e.g., GMP, ISO 13485, and FDA 21 CFR Part 820) and are executed effectively to meet quality requirements.
• Analyze and document validation results, addressing any deviations or non-conformances.
• Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally.
Continuous Improvement and Optimization:
• Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
• Lead root cause analyses for any process failures or deviations, and in collaboration with the Quality Department implement corrective and preventive actions (CAPAs) as necessary.
• Work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Production, to align on process requirements and project timelines.
• Provide technical expertise and training to manufacturing staff on new processes, equipment, and quality standards.
• Collect and analyze production data to monitor process performance and identify areas for improvement.
• Generate reports, metrics, and presentations for management, summarizing process performance, validation activities, and improvement initiatives.
Regulatory Compliance and Documentation:
• Ensure all production processes comply with medical device regulations and standards, including FDA, GMP, ISO, and other applicable guidelines.
• Prepare, review, and maintain comprehensive documentation related to process design, validation, and improvement activities.
• Participate in audits and regulatory inspections, providing technical support and documentation as required.
Equipment Management and Maintenance:
• Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally.
• Support the installation and validation of new equipment, ensuring it meets process requirements and regulatory standards.
Flexible work model
Work globally, hired locally
Global environment
Fast growing trajectory
Career opportunities
Fast paced & entrepreneurial culture
Required Experience & Qualifications
Beneficial Qualifications
Personality
Other information
Why should you join our team?
Nordberg Medical is a Swedish biotech company working at the forefront of biomaterial science to reverse functionality loss. With state-of-the-art biomaterials, we produce and market innovative medical products that target structural imbalances associated with aging.
In 2021, we passed a critical milestone by receiving CE certification for our first product. JULÄINE™ of Sweden is a biostimulator that activates natural collagen production in the skin. This positions the company well to pursue an ambitious growth strategy in the aesthetic dermatology market.
Backed by leading investors and extensive R&D, we are expanding across multiple therapeutic areas and geographies.
Join an international team of highly talented individuals where your contribution counts. We promote a culture of entrepreneurship, multiculturalism, and flexibility in more than ten countries. At Nordberg Medical, you will have the opportunity to grow and learn, to be creative, and to contribute to both our product and company success.
Add the title below:Our values
EXCELLENCEAt Nordberg Medical we understand excellence as an unwavering commitment to providing the market with outstanding products and services with the overall goal to build long-term partnerships with our medical community and patients.
AUTHENTICITYWe believe that the best way to offer excellent products and services and to build valuable relationships is by authenticity. At Nordberg Medical we understand authenticity by carrying our work ethically, and by communicating with our medical community and patients directly and with honesty.
TRUSTTo achieve excellence and authenticity we strive to inspire trust in our relationships with all stakeholders by nurture. Nordberg Medical is a first-class partner committed to supporting our stakeholders to achieve excellence.
Emelie Wedin | Contact Person