Additional Location(s): N/A
About the RoleJoin the Interventional Cardiology & Vascular Therapies division as a Senior R&D Compliance Engineer supporting new product development and sustaining engineering. In this role, you will lead IEC 60601 product safety and compatibility compliance activities.
You will apply established and emerging technologies to help deliver safe, effective medical devices that advance Boston Scientific's mission for patients and clinicians.
Work model, sponsorship, relocation:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Maple Grove, MN office at least three days per week. 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:- Lead IEC 60601-1 product safety planning, protocol development, testing, and reporting for new and sustaining products.
- Coordinate with third-party Nationally Recognized Testing Laboratories (NRTL's) on quotations, purchase orders, test planning, and schedules.
- Evaluate changes to international standards and determine their impact on company products.
- Communicate compliance status, risks, and decisions clearly and promptly to stakeholders.
- Partner with engineering, quality, sourcing, purchasing, manufacturing, regulatory, clinical, marketing, and other functions to achieve project objectives and IEC 60601 compliance.
- Provide technical guidance, training, and work direction to technicians, interns, and engineers as needed.
- Analyze complex engineering issues and recommend effective corrective or alternative actions.
- Champion patient safety and product quality by adhering to all applicable quality processes and procedures.
Required Qualifications:- Bachelor's degree in electrical, computer, mechanical, or a related engineering discipline with 3+ years of relevant experience; or a master's degree with 1+ years of relevant experience.
- Subject-matter expertise in IEC 60601-1.
- Experience applying IEC 60601-1-2; advanced EMC expertise is preferred but not required.
- Self-directed, proactive approach to coordinating cross-functional teams and NRTLs to meet project needs.
Preferred Qualifications- Strong organizational, communication, and collaboration skills.
- Experience with medical device design controls and documentation systems, such as Windchill.
- Experience with medical capital equipment, including medical electrical equipment and systems.
- Experience with CAD drawings or electrical schematics, bill-of-materials management, and manufacturing or supplier transfers.
- Ability to synthesize diverse technical inputs, draw sound conclusions, and make well-supported recommendations.
Requisition ID: 634219 Minimum Salary: $ 85000 Maximum Salary: $ 161500 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.
