Additional Location(s): US-MA-Marlborough
About the role:Join our Endoscopy Sustaining R&D team, where we protect product quality, compliance and business continuity across a portfolio of commercial medical devices. Our engineers improve and optimize released products, solve complex technical challenges, and ensure Endoscopy technologies continue to meet the needs of patients, physicians, and the business throughout their lifecycle.
We are seeking a dynamic and collaborative
R&D Engineer- Sustaining(P3) to support sustaining R&D initiatives, including product improvements, design changes, supply continuity projects, technical investigations, and lifecycle management activities. In this role, you will work in a cross-functional team to monitor product, material, process, and documentation changes; execute technical projects, and ensure commercial products continue to meet customer, patient, business, quality, and regulatory expectations.
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local 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:- Support sustaining R&D activities for commercial Endoscopy products, including product improvements, design changes, test method development, design verification, and lifecycle management initiatives.
- Investigate technical, quality, supplier, or manufacturing issues; assess root cause; evaluate design or process alternatives; and recommend sound engineering solutions.
- Design, coordinate, and execute engineering tests and experiments; summarize, analyze, and draw conclusions from technical data to support decisions and recommendations.
- Assess the feasibility, robustness, and technical soundness of proposed product, material, process, tooling, fixture, or equipment changes.
- Prepare and review engineering documentation, including design change assessments, test protocols, technical reports, design history file deliverables, risk documentation, and regulatory submission inputs.
- Work closely with project management, quality, manufacturing, process development, regulatory affairs, clinical, marketing, and other cross-functional partners to ensure successful execution of sustaining engineering projects.
- Plan and schedule individual and small-team activities needed to meet project milestones and business objectives with limited supervision.
- Present project status, technical findings, risks, and recommendations to technical and cross-functional stakeholders.
- Demonstrate a strong commitment to patient safety and product quality by maintaining compliance with applicable quality system and regulatory requirements.
Required qualifications:- Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or a related technical field.
- Minimum of 3 years of engineering experience in product development, sustaining engineering, or a related technical role.
- Experience analyzing technical data, drawing conclusions, and making recommendations based on inputs from multiple sources.
- Strong problem-solving skills, technical judgment, and ability to work through ambiguity with a hands-on approach.
- Working knowledge of quality systems, design controls, and regulatory standards, including ISO 13485 and/or 21 CFR 820.
- Ability to collaborate effectively across functions and communicate technical information clearly to technical and non-technical audiences.
Preferred qualifications:- Experience working in the medical device industry, preferably in a regulated R&D or sustaining engineering environment.
- Experience supporting design changes, post-launch product improvements, supply continuity, complaint reduction, or product lifecycle management initiatives.
- Experience with test method development, design verification, design validation, risk management, and design history file documentation.
- Demonstrated success working within global, cross-functional teams that include quality, manufacturing, regulatory, clinical, marketing, operations, or supplier partners.
- Familiarity with Endoscopy devices, anatomy, therapies, or related clinical applications.
- Strong time management, project coordination, and communication skills with the ability to manage multiple priorities.
Requisition ID: 631324 Minimum Salary: $ 82100 Maximum Salary: $ 156000 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.
