Über
US–MA–Marlborough; Costa Rica–Coyol
Work mode:
This hybrid role is based in Marlborough, MA and requires being on-site at least three days per week. We will consider candidates based in Coyol, Costa Rica.
Relocation assistance:
Relocation assistance may 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.
This Senior Design Quality Engineer supports quality engineering methodologies, systems, and practices that meet Boston Scientific, customer, and regulatory requirements. A Quality representative for the Sustaining Engineering team, the role focuses on improving awareness, visibility, and communication of quality initiatives and provides support for Design Changes that align with Value Improvement Process Initiatives.
Your Responsibilities Include
Creative and resourceful problem‑solving for moderate to complex mechanical and electrical devices.
Assist with troubleshooting to the component level, moderate to complex mechanical assemblies.
Work within a team of Sustaining Engineers embedded in R&D and Quality Assurance groups.
Actively contribute to all aspects of Design Quality Assurance activities in an FDA/EUMDR‑Regulated Class II Medical Device Software environment including interconnected systems.
Support design, development, and testing of finished devices and accessories used in Boston Scientific Endoscopy product lines throughout the Development Life Cycle.
Participate in product, system, and sub‑system level design reviews focusing on device design evaluation, product risk mitigation, and required Risk Management activities.
Support the creation and execution of validation protocols to perform sub‑system and system level testing and report any issues discovered.
Create and review risk management documentation such as Hazard Analysis, Task Analysis, DFMEA, and FTA.
Create and review DQA documentation as required (e.g., Hazard Analysis, DSME, Design Validation and Usability Engineering related documentation).
Develop subject‑matter expertise for design controls and risk management requirements for the supported products.
Support all aspects of DQA activities during internal and external audits, as needed.
Apply systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
Perform other duties as required.
Required Qualifications
BS in Biomedical, Mechanical Engineering, or equivalent technical discipline.
Minimum of 5 years of medical device engineering experience.
Working knowledge of FDA, ISO, EUMDR quality requirements for product development, design controls, risk management, usability engineering, and medical device software.
Detailed understanding of US and International regulations including 21 CFR part 820, MD Directive/Regulation, EN ISO 13485, EN ISO 14971.
Strong communication and presentation skills.
Competent with Microsoft Office Suite and Minitab statistical analysis software (or equivalent).
Ability to collaborate and work on a global team.
Position located in Marlborough, MA or Coyol, Costa Rica.
Travel approximately 10‑15% of the time.
Preferred Qualifications
MS in Biomedical, Mechanical Engineering preferred.
6+ years of medical device engineering experience, with 2+ years’ experience with medical device systems.
Working familiarity with FDA QSR, EN ISO 13485, EN ISO 14971, and IEC 60601.
Compensation Minimum Salary: $89,200. Maximum Salary: $169,500.
Compensation is commensurate with experience, education, licensure, and other relevant factors. Salary may be supplemented by variable compensation such as bonus targets and incentives for exempt or non‑exempt roles.
Additional Requirements For United States positions, proof of COVID‑19 vaccination status may be required. This role is safety‑sensitive and requires a prohibited substance test.
Equal Employment Opportunity Boston Scientific is an equal opportunity employer. All recruitment, hiring, assignment, promotion, compensation, and other personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran status, age, disability, genetic information, or any other protected class.
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Sprachkenntnisse
- English
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