Associate Director, Engineering - MDCP Technical Lead

Associate Director Engineering - MdcP Technical Lead

We are seeking a highly motivated individual for the role of Associate Director Engineering - MdcP Technical Lead, supporting the Wilson Packaging Technical Operations Team. This role will serve as the primary medical device and combination product (MdcP) point of contact for the site Packaging Technical Operations team. The MdcP Technical Lead will have responsibilities for supporting the design/tech transfer and sustainment activities of MdcPs at the Wilson site and ownership for various MdcP-related QMS topics to ensure compliant implementation and robust application at the site. Experience in design controls, device risk management, prefilled syringes, autoinjectors, process validation, automation, packaging process, equipment and components, equipment qualification and related regulatory requirements are a must for this position. The ability to apply these in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The Associate Director will routinely face competing priorities, and must manage time effectively, while keeping stakeholders and team members informed with effective communication. This individual is expected to function as an independent contributor or lead a small team of engineers, while supporting global or site-specific projects and commercial operations. The role includes leading, enabling or consulting in the development and execution of strategic plans for new product introductions, new or changes to device assembly and packaging assets (including change control and validation/qualification strategies), problem-solving, and continuous improvement, by working with internal and external partners. This role will work closely with the Wilson site QA and Operations MdcP Leads, Device Development and Technology Lead, PTO Engineers, and our Product Development and Commercialization groups, among others.

Key Functions

Understand the big picture, and how activities link to our Company strategy and business goals. Utilize device risk management tools to build and maintain device or combination product risk management programs in development and life cycle management. Lead or support all risk management efforts for introduction or changes impacting MdcPs at the site. Work closely with internal and external stakeholders to develop and execute a comprehensive risk management strategy that integrates defined control measures, considering patient safety and product quality. Lead technical investigations of medical device and combination product for commercial products. Work with PTO Engineers, Device Development and Commercialization teams on developing validation strategies for new or changes impacting MdcPs, in alignment with Company and regulatory guidelines. Facilitate design and technology transfer of medical device and combination products from development to commercialization. Provide support for completion of regulatory filing sections and support response to questions and pre-approval inspections from a device assembly and packaging process standpoint. Own and maintain in good compliance health QMS technical topics related to MdcP such as design controls, tech/design transfer, process validation, etc. Support regulatory inspections and maintain proficiency in ISO 13485 and other relevant quality management systems. Demonstrate the necessary inclusion skills to integrate inputs and perspectives from various sources, and communicate the decision to team members, key stakeholders and sponsors. Solicit feedback to ensure that customer/stakeholder needs are the cornerstone of decisions and expectations. Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company's divisional and local site procedures.

Education

Required | BS degree or higher in Engineering or related field Preferred | BS or higher in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar

Experience | Skills | Knowledge

Required Eight (8) years of relevant combined experience in medical device and combination products (MdcP) and packaging Demonstrated technical leadership in medical device and combination product manufacturing, assembly and packaging sites and functional areas Experience with medical device or combination product commercialization, operations support, and materials/components Experience with autoinjectors or other complex drug-delivery systems and associated pre-filled syringe systems or cartridges. Experience with device assembly and packaging equipment/processes Experience in deviation management, change control, process scale up, process validation, equipment qualification, and the fundamentals of Quality Management system documentation structure/systems Proficiency in project management Principled verbal and written communications Preferred Eight plus years in medical device, pharmaceutical or in biotech organizations Eight plus years in design control, risk analysis and change control management for medical device or combination products Experience in design controls, ISO 13485, risk management/ISO 14971-2019 Experience with design verification testing Experience in supporting regulatory inspections. Experience in commercialization of high-volume medical device or combination products Experience with injection molding and working with medical device suppliers Required Skills: Combination Products, Compliance Packaging, Engineering Standards, Good Manufacturing Practices (GMP), Injection Moldings, Manufacturing Scale-Up, Mechanical Engineering, Medical Device Management, Medical Devices, Packaging Engineering, Packaging Processes, Plastic Injection Moulding, Process Optimization, Product Risk Management, Regulatory Compliance, Regulatory Inspections, Technical Leadership Preferred Skills: