Principal R&D Sustaining Engineer

Working Location: Massachusetts, Westborough

Workplace Flexibility: Hybrid

For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling.

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers.

Job Description

The Principal 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. They 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 and mentor less experienced engineers within and across OSTA sites in best practices for the use of engineering tools and methods.

Job Duties

• Provides technical leadership on Sustaining / Systems projects and/or development efforts.
• Accountable for 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.
• Directs or performs design analysis, such as tolerance stack-ups, strength of materials, risk analysis, and statistical evaluations.
• Ensures product designs are cost effective, manufacturable, and products are tested through well thought out verification plans to ensure a high degree of product quality and reliability.
• Consults with the Sales, Marketing, and clinicians to define and specify product user requirements.
• Manages, directs and supports suppliers involved in product development and ongoing production. This includes outside design and/or development/manufacturing partners.
• Helps prepare and acts as a consultant to marketing on technical brochures, training programs, and technical presentations to customers and the sales force.
• Drives Design History File remediation efforts and CAPA projects as needed.
• Supports engineering leadership as required.

Job Requirements

Required:

• Bachelor's degree in Biomedical, Mechanical Engineering, Electrical Engineering or similar.
• Minimum of 9 years of related experience or 8 years with MS or 5 years with PhD.
• Ability to effectively work within a requirements management system.
• Previous experience in design, development, and sustaining of Medical Devices.
• Must have extensive working knowledge of, and experience in applying / developing products in compliance with FDA and international requirements, including 820-CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.
• 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 including geometric dimensioning and tolerancing and tolerance analysis.
• Knowledge of common manufacturing methodologies, technologies, and materials, such as; injection molded part design, common materials employed in medical devices, and other manufacturing processes.
• Must be able to solve complex and/or ambiguous problems using good judgement as well as logical and systematic thinking.
• Capable of providing problem solving guidance to other engineers.
• Must be able to use good judgement in making timely decisions.
• Able to balance risk vs. benefits in a variety of situations.
• Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.
• Must be able to manages resources and drives for results.
• Must be able to communicate effectively at all levels, both verbally and in writing.
• Strong presentation skills and the ability influence.
• Inspires and motivates others and provides work direction.
• Travel up to 15%.

Preferred:

• Experience in the practical application of statistics and working knowledge of a statistical analysis package (Stat Ease, Minitab are 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 $137,657.00 - $192,722.00 / 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.

At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let's realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Research and Development