Additional Location(s): N/A
About the role:At Boston Scientific, we are seeking a hands-on Manufacturing Supervisor to lead daily operations for the assembly, testing and production of laser-based console systems classified as Class II medical devices.
In this role, you will provide technical leadership, oversee manufacturing performance and foster a culture of quality, safety and continuous improvement. You will work closely with cross-functional teams to ensure manufacturing processes comply with applicable regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820, while delivering high-quality products that meet customer needs.
This is an opportunity to lead a dedicated manufacturing team, drive operational excellence and contribute to innovative medical technologies that improve patients' lives.
Work model, sponsorship, relocation:This position follows an on-site work model, requiring employees to work at the designated Boston Scientific facility.
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Your responsibilities will include:- Supervise daily manufacturing operations, including production scheduling, assembly, testing and packaging of laser-based medical console systems.
- Provide technical guidance, coaching and operational support to manufacturing technicians and assemblers to achieve production and quality objectives.
- Monitor key performance indicators (KPIs), including throughput, yield, efficiency and scrap, and implement continuous improvement initiatives to optimize manufacturing performance.
- Ensure compliance with applicable Good Manufacturing Practices (GMP), ISO 13485, FDA 21 CFR Part 820 and established quality management system requirements.
- Collaborate with Quality, Engineering and Supply Chain teams to resolve nonconformances, implement process improvements and support design transfers and manufacturing validations.
- Maintain accurate and complete manufacturing documentation, including work orders, device history records (DHRs) and batch records, in accordance with applicable regulatory requirements.
- Lead root cause investigations, support corrective and preventive action (CAPA) activities, and document deviations to ensure timely and effective resolution.
- Train, mentor and develop manufacturing team members on standard operating procedures, safety protocols, technical processes and product knowledge.
- Support the implementation of engineering change orders (ECOs), process validations, including installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and equipment qualification activities.
- Ensure proper calibration, preventive maintenance and safe operation of laser systems, manufacturing equipment and production tools.
- Promote and enforce workplace safety, 5S methodology and lean manufacturing principles to maintain an organized, efficient and compliant production environment.
- Foster a culture of accountability, teamwork, quality and continuous improvement while supporting employee engagement and development.
Qualifications:Required qualifications:
- Associate or bachelor's degree in engineering, manufacturing or a related technical discipline, or equivalent experience.
- Minimum of 5 years' experience in a regulated manufacturing environment, preferably within the medical device industry.
- Minimum of 2 years' experience in a direct supervisory or team leadership role.
- Working knowledge of laser system assembly, optics handling or electromechanical integration.
- Knowledge of ISO 13485, FDA 21 CFR Part 820 and applicable GMP requirements.
- Strong problem-solving, communication and leadership skills, with the ability to guide teams and resolve manufacturing challenges.
Preferred qualifications:
- Experience implementing laser safety protocols and working with Class 3B or Class 4 laser systems.
- Experience supporting design transfer, new product introduction (NPI) or manufacturing scale-up activities.
- Experience using enterprise resource planning (ERP) systems and digital work instructions.
- Lean Six Sigma certification or training in continuous improvement methodologies.
- Working conditions:
- Ability to work in a fast-paced manufacturing environment that requires prolonged standing, walking and occasional lifting of up to 50 pounds.
- Ability to follow cleanroom or controlled-environment protocols, as applicable.
- Ability to use required personal protective equipment (PPE) and laser safety equipment in accordance with established safety procedures.
Requisition ID: 635938Minimum Salary: $ 89200 Maximum Salary: $ 169500 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.
