Boston Scientific Associate Director Sterility Assurance 

United States, Minnesota, Maple Grove 

459780352

The Associate Director, Sterility Assurance, will serve as the global technical leader in design for sterilization in support of new product development across all divisions of BSC. You will have managerial responsibility for a high performing team of subject matter experts in sterility assurance, sterilization modalities, microbiological methods, device reprocessing and microbiological quality. You will build and maintain your and your teams state of the art knowledge and capabilities by actively networking with the internal and external scientific, technical and regulatory communities.

Your responsibilities will include:

• Influencing the company’s strategic and tactical directions and financial results globally through the application of technical leadership, knowledge, and expertise.
• Supporting new product development, collaborating with product teams and suppliers to provide design inputs as well as to validate sterile and microbiologically controlled products.
• Cross-functional collaboration and influence across multiple divisions and functions including quality, regulatory, global supply chain, and R&D.
• Developing strategies with respect to design for sterilization, sterilization modality selection, sterilization cycle design and product validation approaches.
• Providing input in the design of manufacturing processes, controlled environments and packaging from a microbiological standpoint.
• Conducting research into novel sterilization modalities, or novel applications of existing sterilization modalities and their impact on materials and product functionality and lethality.
• Interacting with external regulators and various levels of company management, working across many functional areas.

Required qualifications:

• Bachelor’s degree with Engineering, Microbiology, Biology, Chemistry or related discipline.
• 10+ years of experience in a medical device industry with a GMP and/or ISO regulated environment.
• 5+ years of direct people leadership experience is required.
• Experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility.
• Demonstrated capability to lead and train a diverse, multinational community of practice with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity.
• Experience in interacting with Regulatory Authorities.
• Demonstrated competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).
• Proven track record on trouble shooting microbiological and/or sterilization process non-conformances and out of specification test results and providing resolution to issues via robust CAPA.
• High level knowledge of standards including AAMI and ISO.
• Must be able to travel 20% of the time (domestic and global)

Preferred qualifications:

• Master’s or PhD degree in Microbiology, Biology, Engineering or related discipline.
• Competency in additional technical areas such as reprocessing and microbiology laboratory operations experience
• Experience with conducting technical assessments of in-house and contract sterilization processes or contract microbiological laboratories

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.