Marlborough, MA
You will conduct development and/or design integration work as part of a major acquisition / integration project. The Principal R&D Engineer would be viewed as an expert in Product Design History File (DHF) integration and/or associated medical device technologies.
Your responsibilities include:
- Identifying gaps in the acquired company’s compliance to Boston Scientific Work Instructions and SOPs and defining strategy to close these gaps.
- Directing day-to-day work of less experienced engineers and technicians within core product integration team and delegating work appropriately to meet project goals.
- Coordinating, managing, and documenting project goals and progress and recommending appropriate revisions.
- Communicating progress, risks, and trade-offs of technical deliverables to project leadership, and recommends revisions as needed.
- Driving complex or novel assignments requiring the development of new or improved techniques and procedures. Work is expected to result in efficient and effective integration of medical device technologies to the Boston Scientific portfolio.
- Successfully completing engineering work in one or more of the following: technology development or remediation, product design refinement, test of materials, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
- Providing guidance to product and technology teams.
- Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
- Developing and coaching others on engineering documentation.
- Demonstrating Technology Development and Product Development system knowledge through coaching and delivery of high quality, high impact deliverables.
Required Minimum Qualifications:
- Bachelor’s degree or above in Mechanical Engineering, Biomedical Engineering, or related field
- 8+ years of Medical Device Engineering experience with Bachelor’s degree, or 6+ years with Master’s
- Ability to provide technical leadership as it relates to product design and prioritization and to delegate work appropriately
- Strong mechanical and/or systems engineering and problem-solving skills
- Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
- Strong written and verbal communication, judgment, decision-making, and critical thinking skills
- Excellent organizational, communication, and collaboration skills
- 15% travel
- Willing to work onsite 3+ days per week at our Marlborough, MA location
Preferred Qualifications
- Understanding of IEC 60601 Medical Electrical Equipment standards, including laser-specific sections
- Experience in single-use device or medical electrical equipment
- Experience with System Design Verification testing and data analysis
- Experience with Minitab
- Ability to build strong relationships across the organization and with external stakeholders
- Experience in driving technical trade-off decisions to optimize design, performance, usability, manufacturability, cost-efficiency and reliability
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement/ The foal of the drug testing is to increase workplace safety in compliance with the applicable law.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.