Job Description

Recruiter: Spencer Gregory Hale

Supplier Quality Engineering Manager

Remote Eligible: Hybrid (3 days onsite/2 days remote)

Onsite Location(s): Marlborough, MA; Arden Hills, MN; Maple Grove, MN; Carlsbad, CA; Valencia, CA

About this role:

The External Operations (ExOps) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineering Manager will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes. In this role, you will support Sourced Finished Medical Device (SFMD) products within a newly acquired company, with a primary focus on Single-Use Devices, Capital Equipment, and Capital Equipment Accessories. This role is intended to support acquisitions with the Cardiac Rhythm Management, Electrophysiology, and Neuromodulation divisions. Your role will deliver improvement in supplier process capability and product performance, reducing risk related to sustaining acquired finished devices and integrating supplier and material controls into BSC standard processes. Your role will also influence the development of early-career and experienced engineers to provide stretch opportunities, guidance, and critical feedback to support the needs of the business and the growth of the engineer.

Your responsibilities will include:

People Leadership:

• Monitors daily work operations and provides direction and guidance to experienced exempt employees to achieve unit or project goals.
• Preparation of key metrics and data to show progress and adherence to schedule and to monitor progress and improvement in the area of supplier quality.
• Translates department goals into individual objectives and strategic projects.
• Identifies, develops and implements processes to improve functional performance.
• Monitors functional activities and records to ensure compliance through critical decision making.
• Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.

Sustaining Engineering:

• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
• Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Manages sustaining quality issues, process change impacts, and design change implementations for suppliers within the Acquired Entity Quality system, the hybridized BSC-Acquired Entity Quality System, and in the BSC Quality System after products are successfully integrated.
• Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
• Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
• Investigates complaints and manages NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing-related.
• Supports Supplier Change Impact Assessments for process changes at suppliers.
• Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
• Leads projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process.

New Product Development:

• Execute and manage initial onboarding deliverables to support initial distribution of Acquired Entity’s products through BSC Distribution Centers.
• Execute and manage SFMD Plan deliverables for integration of acquired company’s suppliers and products into BSC’s Quality System.
• Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.

Quality System Champion:

• Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
• Identifies and advises management on potential improvements to quality systems and processes in the company.
• Champions 100% compliance to company policies and SOP’s.

• Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.

What we are looking for

Basic Qualifications

• Bachelor’s degree required in engineering, science, or another technical discipline
• 7+ years of progressive quality engineering experience working with functional areas across divisions/sites
• Strong facilitation & communication skills with the ability to successfully interact at all levels of the organization with proven ability to lead individuals, complex projects, and solve difficult technical problems.
• Highly adaptable, willing to accept new ideas, and ability to create, influence, and implement global strategies and policies successfully
• Articulate communicator: adept at packaging and appropriately scaling information to the intended audience.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
• Domestic and international travel up to 25%.

Preferred Qualifications

• 7+ years of medical device engineering experience preferred.
• Global Sourcing or Operations experience preferred

• MBA, advanced degree
• New Product development experience and partnering with R&D and Project Management groups
• Lead auditor of quality systems experience (ISO 13485 or similar).
• ASQ certification (CQE, CBA, SSGB, SSBB) desired.
• Previous experience with technology and supplier acquisition & integration
• Experience leading virtual teams
• Experience recruiting & developing a high-performance technical team
• Ability to interface with internal customers to gather insight

Requisition ID: 629057

Minimum Salary: $ 102100

Maximum Salary: $ 194000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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