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Title:  Sr Manager, Product Sustainment Engineering, Medical Devices

Requisition ID:  35547
Date:  Oct 17, 2021
Location: 

Scottsdale, Arizona, US

Department:  R&D
Description: 

 

 

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 Sr Manager, Product Sustainment Engineering, R&D, has the responsibility for collaborating with customers and internal stakeholders, executing a scalable strategy to sustain commercial medical device products including lifecycle management, design control compliance, product analysis and post launch design changes.

 

This role will develop a sustainable plan of execution for assigned commercial medical device programs with participation from commercial, product management, quality, regulatory and operations. Directing assigned cross-functional teams with constant monitoring and adapting to changing needs with appropriate risk management strategies.  This role is responsible for the management and reporting of all applicable data for the project/program. They will communicate at all levels of the organization and be responsible for recognizing and engaging key stakeholders and cross-functional resources throughout the process.

 

Essential Duties and Responsibilities:

  • Develop and drive sustainment strategy for the platform including development of product improvement roadmaps and implementation as well as identification of key capabilities needed for scale and growth.
  • Lead technical team for product line extensions, including feasibility evaluations and conducting formal product design control activities (21CFR 820.30).
  • Lead technical staff in the role of Design Authority when changes to the product specifications and requirements or manufacturing process are requested. 
  • Serve as a customer interface to obtain product performance in the field and support customer specific product line extensions.
  • Responsible for codevelopment of a configuration management strategy, collaborating with key resources both on the platform and shared services to build a scalable and efficient system aligned with business growth needs. This role will also coordinate efforts on the synchronization of design verification/validation with process validation activities and implementation.
  • Lead product review and impact assessments, at predefined frequency, to industry standards (IEC 60601, ISO 11608, ISO 14971, ISO 10993, etc.), customer contracts, regulatory requirements.
  • Ensure product risk management files, including periodic reviews, are maintained
  • Provide support as needed  to product analysis team on investigation of product complaints to determine root cause and identification potential corrective actions.
  • Develop strategy and partner and/or liaison with all functional groups (R&D, Operations, Quality, etc.) to ensure that smooth and timely transfer of new products into operations and assist in the optimization of processes, procedures, and products.
  • Will provide feedback of commercial products to the R&D and Product Management organization and identify potential new portfolio opportunities.
  • Plans and formulates engineering program and organizes a technical staff according to work requirements.  Strong knowledge of standard West manufacturing equipment and processes, including but not limited to; Polymer Injection Molding, Automated and Manual assembly, Robotics, and Sterilization.
  • Demonstrates strong leadership and communication including appropriate use of delegation, empowerment, and coaching while maintaining accountability for overall functional performance.
  • Proactively identifies and solves complex and impactful engineering issues.Understands customers’ requirements and needs post development through end-of-life and will communicate, track and monitor performance to customers and West stakeholder.
  • Establish and lead communication plan, governance and change controls with customer and West stakeholders to drive mutually beneficial and predictable results during combination product development process.
  • Coordinate resource allocation & constraints with functional managers, program managers.
  • Communicates key messages, goals, and objectives to team members in their local geographies or business units to drive alignment and a high-performance culture. 
  • Performs other duties as assigned based on business needs.
  • Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

 

 

Education and Experience:

  • Education: Bachelors in Engineering, Materials, Chemistry, or equivalent technical degree. MBA/Masters degree preferred
  • Experience: 10+ years of experience

 

Knowledge, Skills and Abilities:

        • 5+ years Medical Device &/or Drug Delivery Systems product development experience. 
        • Working knowledge of applicable federal & international regulations such as 21CFR Parts 210, 211, & 820. 
        • cGMP manufacturing experience preferred. 
        • Proficient with Microsoft Office suite software, project management software such as Microsoft Project Server.
        • Working knowledge of 3D design applications preferred.
        • Ability to lead complex teams in a matrix structure.

 

Physical and Travel Requirements:

        • Must be able to travel to domestic & international customers as well as West manufacturing locations as project requirements & business needs require.
        • Work in an office/home office environment.  At times required sit or stand for extended periods of time. 
        • Ability to effectively communicate and comprehend complex ideas and concepts. 
        • Use written and oral communication skills. 
        • Read and interpret data, information, and documents. 

 

 

 

 

 

 

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 kimberley.eby@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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