Additional Location(s): N/A
About the role: We are looking for a dynamic Design Quality Manager to lead a team of engineers supporting the growing Neuromodulation Relievant ( Intracept RF ) franchise. In this role you will work with high-performing cross-functional Sustaining Engineering and New Product Development teams to maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.
Work mode: At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Valencia, CA and requires being on-site at least three days per week.
Relocation assistance:Relocation assistance might be available for this position at this time.
Visa sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your Responsibilities will include: - Assists in and/or manages functional deliverables and ensures technical excellence for Sustaining Engineering and New Product Development.
- Drives functional excellence in Design Quality Assurance by providing leadership, coaching, and mentoring on product design and development, including Risk Management, Design Controls, and Post-Market Surveillance.
- Provides leadership, guidance, and approval regarding Quality initiatives including product performance.
- Reviews and approves verification and validation plans, protocols, reports, and non-conforming product assessments.
- Works cross-functionally in identifying and resolving technical issues, takes a proactive role in collaborating across the organization to mitigate issues.
- Works with project managers and functional leaders (R&D, Supplier Quality Engineering, Marketing, and Regulatory) to understand priorities, plan resources, and allocate time.
- Explores opportunities for staff to learn about new initiatives and participate on new projects.
- Drives and evaluates process and results for project and department objectives.
- Recruits, hires, trains, and develops world-class staff.
Management requirements:
- Leads a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and drive best practices throughout their organization.
- Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Directs and controls the activities and budget of one or more functional areas and/or projects/programs.
- Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
- Influences others to build collaborative relationships, achieve goals and effectively guide them to understand more complex issues.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
What we're looking for in you: Required qualifications
- Bachelor's Degree in engineering such as Mechanical Engineering, Electrical Engineering, Materials Science and/or Biomedical Engineering, or equivalent
- Bachelor's degree plus 8 years of related work experience or an equivalent combination of education and work experience.
- Proven technical leadership and project management skills in medical device design, development, commercial launch, and product sustainment.
- Knowledge/Experience of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations.
- 2+ years of experience mentoring
Requisition ID: 630232 Minimum Salary: $ 106800 Maximum Salary: $ 202900 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.
