Working Location: Massachusetts, Westborough

Workplace Flexibility: Hybrid

Job Description

The Sr. Engineer is responsible for performing and/or leading all aspects of Sustaining including technical planning, feasibility studies, device development, investigations and corrective actions, cost reductions, verification, and validation activities. The primary responsibility of the position is the technical maintenance of the Design History File and Technical Files post launch. He or she must fully understand medical device design control requirements and be able to effectively manage a project and work effectively in a cross functional team. May serve as a core or extended team member on projects. Maintains detailed documentation throughout all phases of research and development.

May provide leadership and direction to Engineering Technicians.

Job Duties

• Provides leadership to sustaining/product development projects and/or technology development efforts.
• Contributes to all aspects of product development activities and product Design History File, such as requirements creation/documentation, ideation / prototyping, design / development, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supports the compilation of documents to enable regulatory submissions.
• Develops engineering solutions, investigates competing technologies, and collaborates with Olympus Patent Attorneys to secure a strong IP portfolio as needed.
• Supports or leads efforts to evaluate and identify design solutions which meet product/performance requirements, cost targets, and manufacturability requirements.
• Develops product verification testing protocols and reports and ensures products meet/exceed established specifications.
• Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
• Supports in ensuring product and performance specifications are appropriate and accurate.
• Supports internal and external suppliers and manufacturers as needed. Including external design and/or development partners.
• Supports Design History File remediation efforts and CAPA projects as needed.
• Supports engineering leadership as required.

Job Qualifications

Required:

• Bachelor's degree in Biomedical, Mechanical Engineering or similar discipline.
• Minimum year of related experience: 5+ years or 4+ years with MS or 0-2 years with PhD.
• Experience in Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process.
• Working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820-CFR, ISO14971, ISO10993, IEC60601, GMP, etc.).
• Capable of developing many of the deliverables required to document the product design with appropriate specificity to enable high volume manufacturing with high quality.
• Proficient in Microsoft Windows Office applications including MS Outlook, MS PowerPoint, MS Project, Visio, etc..
• Solidworks working knowledge. Proficient in the creation and critical review of engineering drawings, tolerancing and tolerance analysis.
• Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
• Must be able to solve complicated technical challenges and use good judgement in making timely decisions.
• Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab).
• Must be able to collaborate effectively with others, works well within cross-functional teams and across multiple sites, as applicable.
• Must be capable to effectively executing on multiple work streams in parallel.
• Must be able to communicate effectively, both verbally and in writing. Comfortable presenting information to team members and stakeholders.
• Must be able to work in a professional open-space environment without distracting others.
• Must have a positive attitude and capable of accomplishing efforts in a timely manner and with high quality.

Preferred:

• Experience in hand-held electro-mechanical devices is preferred.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position in this location is $100,263.00 - $135,355.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.