Additional Location(s): US-MN-Minnetonka; US-MA-Marlborough
About the RoleThe Principal Design Quality Engineer will support the Valencia Technologies Integration project with a focus on New Product Development. This role is responsible for leading Design Assurance activities throughout the product development lifecycle, ensuring products and processes remain safe, effective, high quality, and compliant with Boston Scientific and global regulatory requirements.
Work ModeAt Boston Scientific, we value collaboration and synergy. This role follows a hybrid work mode requiring employees to work onsite at least three days per week. This position is based in Minnetonka, MN or Marlborough, MA.
Relocation AssistanceRelocation assistance is available for this position.
Visa SponsorshipBoston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.
Key Responsibilities- Serve as the quality representative within cross-functional development teams, influencing project strategy, driving compliance to Design Control and Risk Management requirements, and ensuring alignment with regulatory and business objectives.
- Lead Design Assurance activities throughout product development for an active implantable technology.
- Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality-related issues.
- Author and maintain Design History File (DHF) documentation, including design inputs/outputs, technical rationales, verification/validation documentation, and risk management deliverables in compliance with internal and external requirements.
- Lead and support product risk management activities throughout the product lifecycle, including hazard analysis, fault tree analysis, FMEA, usability risk assessments, and post-market risk evaluation.
- Partner with R&D, Manufacturing, Regulatory, and other cross-functional teams to establish and implement Design Controls based on Risk Management, customer needs, and manufacturing inputs.
- Support verification, validation, and usability testing activities to ensure products meet internal requirements, regulatory expectations, and customer needs.
- Demonstrate strong working knowledge and application of validation methodologies, statistical techniques, and quality engineering principles.
- Collaborate effectively within a mixed onsite and remote working environment.
Required Qualifications- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline.
- Minimum of 7+ years of experience in Design Assurance, Quality Engineering, New Product Development, or related medical device/regulated industry experience.
- Strong understanding of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, and Design Control requirements for medical devices.
- Demonstrated experience applying Quality Engineering tools and methodologies.
- Strong verbal and written communication skills with the ability to influence across functions and levels.
- Demonstrated experience authoring and reviewing detailed technical documentation.
- Self-motivated with strong problem-solving skills and a bias for action.
- Ability to effectively collaborate in a hybrid onsite and remote work environment.
Preferred Qualifications- Experience working with active implantable medical devices and/or medical electrical equipment.
- Experience supporting acquisition integration and quality system harmonization activities.
- Experience supporting software development lifecycle activities in accordance with IEC 62304.
- Experience facilitating structured problem-solving methodologies and risk-based decision making.
- Experience supporting regulatory inspections and external audits.
- Adaptable and effective collaborator in both team-based and self-directed environments.
Requisition ID: 629871Minimum 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.
