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Title:  Material Biocompatibility Sr. Specialist

Requisition ID:  39141
Date:  Oct 20, 2021
Location: 

Scottsdale, Arizona, US

Department:  R&D
Description: 

Who We Are:

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

The Materials & Biological Safety Sr. Specialist will report to the Director, R&D Labs & Technical Services (Wearable Delivery Systems) and is responsible for supporting all global Wearable Delivery System platforms with materials research, selection, and biological safety (biocompatibility) confirmatory activities. This will include gathering and maintaining basic materials data, performing biological safety risk assessments, testing, and general support of customer and regulatory requests.

 

Essential Duties and Responsibilities:

  • Lead point of contact for internal employees, external clients, and service providers globally regarding materials and biological safety of West Wearable Delivery System device platforms (existing SmartDose and future pipeline wearable devices).
  • Support the design and development teams with materials research, evaluation, and selection. Liaise with Product Design, Validation & Verification and Project Managers/Leads to achieve project goals through high quality, accurate and timely completion of deliverables.
  • Request, review, and manage database of material specification and safety documents (datasheets, MSDS, declarations, CofAs) from suppliers and customers.
  • Manage external/third-party biocompatibility testing service providers (e.g. NAMSA, Nelson, WuXi AppTec) and coordinate testing at external labs.
  • Coordinate builds and procure sample devices from the manufacturing plant for use in biocompatibility and/or chemical characterization evaluations.
  • Create (author) and/or review Biological Risk Assessment (BRA) in preparation for completing biocompatibility testing and chemical characterization programs.
  • Create (author) and/or review and approve biocompatibility test plans, protocols, and reports.
  • Provide general ongoing materials and biological safety support with customer requests/inquiries, regulatory body or customer audits, and regulatory submissions.
  • Responsible for updating and maintaining materials & biological safety local SOPs and be part of the Global ESOP team.
  • Drive continuous improvement initiatives to enhance/improve testing quality and services provided by the technical services tea.
  • Maintain high standards of compliance with Health and Safety, Quality System and Proprietary/Customer requirements.
  • Liaise with other West R&D site materials & biological safety managers/leads to align on Global ESOP’s and global standards requirements.
  • Maintain thorough understanding of relevant quality system and laboratory testing accreditation requirements.
  • Other relevant duties as assigned by manager.

 

Basic Qualifications: 

  • B.S. in Materials Science, Biomedical Engineering, or other relevant field.
  • 5-10 years of experience with materials safety management in the medical devices industry.

 

Preferred Knowledge, Skills and Abilities:

  • Experience in medical device design, development and manufacture with an emphasis on body-worn medical devices.
  • Proven track record in managing Materials & Biological Safety (MBS) in medical device industry.
  • Experience in applying and adhering to relevant global standards and regulations, specifically the ISO 10993 family.
  • Strong technical writing skills for authoring test plans, protocols and reports.
  • Knowledge of medical device Design Controls and Risk Management.
  • Excellent communication, interpersonal skills and service oriented personality.
  • Excellent problem-solving skills as well as keen analytical abilities.
  • Ability to work well independently and as part of a team.
  • Well organized and methodical with high level of proficiency in MS Office suite including PowerPoint, Word, Excel, and Outlook.
     

Travel Requirements:

  • Must be able to travel up to 5% of the time.

 

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West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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