Production Supervisor - 2nd shift at Boston Scientific Corporation Malaysia

Carlsbad, California, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

142600.0

Posted On

14 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership, Manufacturing, Laser Technology, Regulated Manufacturing, ISO 13485, FDA Regulations, Problem-Solving, Communication, Continuous Improvement, GMP Compliance, Technical Guidance, Production KPIs, Training, Safety Protocols, Documentation, Calibration

Industry

Medical Equipment Manufacturing

Description

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. About this role: We are seeking a hands-on Manufacturing Supervisor to lead daily operations for the assembly and production of our laser-based console systems, which are Class II medical devices. The ideal candidate will bring strong leadership, a quality-focused mindset, and working knowledge of laser technology and regulated manufacturing environments (ISO 13485, FDA 21 CFR Part 820). This role is critical in ensuring safety, efficiency, and compliance while delivering high-quality products that meet customer and regulatory standards. Work Mode: At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model, requiring employees to be present in our Carlsbad, CA office at least four to five days per week. Your responsibilities will include: Supervise day-to-day operations of the production floor, including scheduling, assembly, testing, and packaging of laser-based medical console systems. Provide technical guidance and support to manufacturing technicians and assemblers. Monitor production KPIs (throughput, yield, efficiency, scrap) and drive continuous improvement initiatives. Ensure strict compliance with Good Manufacturing Practices (GMP), ISO 13485, and FDA QSR standards. Collaborate with Quality, Engineering, and Supply Chain to resolve non-conformances, implement process changes, and support design transfers and validations. Maintain production documentation including work orders, device history records (DHRs), and batch records in accordance with regulatory requirements. Lead and document root cause investigations, CAPA activities, and deviation reports. Train and mentor team members on procedures, safety protocols, and product knowledge. Support execution of Engineering Change Orders (ECOs), process validations (IQ/OQ/PQ), and equipment qualification. Ensure proper calibration and maintenance of laser systems and production tools. Enforce safety, 5S, and learn manufacturing principles. Required qualifications: Associate or bachelor's degree in engineering, Manufacturing, or related technical discipline (or equivalent experience). 4+ years of experience in a regulated manufacturing environment, preferably medical devices. Direct supervisory or team lead experience. Familiarity with laser system assembly, optics handling, or electro-mechanical integration. Knowledge of ISO 13485, FDA 21 CFR 820, and GMP regulations. Excellent problem-solving, communication, and leadership skills. Preferred qualifications: Experience with laser safety protocols and Class 3B/4 laser systems. Prior involvement in design transfer, NPI, or scale-up manufacturing. Experience with ERP systems and digital work instructions. Lean Six Sigma or other continuous improvement training/certification. Other Duties/ Standards: Working Conditions: Fast-paced manufacturing environment requires standing, walking, and occasional lifting (up to 50 lbs. ). May involve cleanroom or controlled environment protocols. Use of PPE and laser safety equipment as required. Requisition ID: 622361 Minimum Salary: $ 75100 Maximum Salary: $ 142600 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. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 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. 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. 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.

Responsibilities

Supervise daily operations of the production floor, including scheduling, assembly, testing, and packaging of laser-based medical console systems. Ensure compliance with regulatory standards while driving continuous improvement initiatives.