Olympus America Inc. Senior Product Development Engineer in Southborough, Massachusetts
Bachelor’s Degree in Engineering or equivalent in years of industry experience.
Minimum of 5 years of related experience; OR, minimum of 4 years with Master's Degree, or 0-2 years with PhD.
Experience of statistical analysis package (Stat Ease, Minitab).
Working knowledge of the creation and critical review of engineering drawing and specification documentation.
Knowledgeable with geometric dimensioning and tolerance experience.
Working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.
Proficient with Microsoft Windows environment, Outlook, excel, MS project, 3D CAD/CAM software.
Strong problem solving skills.
Use good judgement and makes accurate data based decisions.
Ability to collaborate and work well within cross-functional teams.
Understand managing resources and is able to drive projects to completion, elevates concerns and roadblocks as required.
Ability to communicate effectively at all levels, both verbally and in writing.
Feel confident presenting in front of others.
Embraces changes and can influence others as a change agent.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
Serve as Project leader on Exploratory, Discovery, TRP and TDP Projects.
Maintain responsibility for the design and development of new products.
Work directly with Marketing to define and specify new product user requirements, design inputs for single use electrosurgical medical devices.
Work with vendors involved in product development and ongoing production.
Manage cross-functional product development teams and all associated product development activities.
Develop engineering solutions, investigate competing technologies, research the patent landscape, and protect engineering solutions by filing invention disclosures.
Maintain responsibility for planning, scheduling, and executing all assigned projects.
Develop product verification and validation testing requirements, testing protocols and testing reports to ensure products meet specification.
Design various aspects of medical devices with a focus on design for manufacturability, ergonomics and COGS.
Act as a consultant, as needed, to other internal departments Investigates and solve critical production product/process problems on demand.
Perform design analysis, e.g. tolerance stack-ups, strength of materials (factor of safety), FEA risk analysis, etc. required for new and existing products.
Perform all other essential duties as assigned.
Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. We’re currently looking for a Senior Product Development Engineer to join us in our Southborough, MA office.
Let’s inspire healthier lives, together.
The Senior Product Development Engineer is responsible for all aspects of product development including performing technical planning, device integration, verification and validation. The major responsibilities of the position are defining product specifications, design inputs, product design, verification testing and supporting design validation studies. Other activities include evaluating alternatives including cost and risk, supportability and analyses for total device. He/She must fully understand medical device design control requirements and be able to effectively manage a product development project and work effectively in a cross functional team. The incumbent conducts feasibility studies of the design to determine ability to function as intended. He/She maintains detailed documentation throughout all phases of research and development. The incumbent may serve as a core or extended team member on PRP/NPD projects. He/She may provide leadership and work direction to Engineering Technicians.
At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.
We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.
TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.
Olympus Surgical Technology America
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
Olympus Surgical Technology America at http://www.olympus-osta.com/
Senior Product Development Engineer
Southborough GYR ACMI Inc
Research & Development
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Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.