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Olympus Corporation of the Americas · 2 days ago
Staff Sustaining Engineer
Westborough, MA
Full-time
Onsite
Senior Level
5+ years exp
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Maximize your interview chancesMedical Device
Insider Connection @Olympus Corporation of the Americas
Responsibilities
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 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.
Qualification
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Required
Bachelor’s degree in biomedical, Mechanical Engineering, Electrical Engineering or similar.
Minimum of 7 years of experience with MS or 5 years with PhD.
Preferred
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.
Experience in the practical application of statistics and working knowledge of a statistical analysis package (Stat Ease, Minitab are preferred).
Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.
Must be able to manage resources and drive for results.
Must be able to communicate effectively at all levels, both verbally and in writing. Strong presentation skills and the ability to influence.
Inspires and motivates others and provides work direction.
Other Considerations (travel/hours availability, etc.): Travel up to 15%
Benefits
401(k) with company match
Comprehensive Medical, Dental, Vision coverage
24/7 Employee Assistance Program
Free virtual live and on-demand wellness classes
Work-life balance supportive culture with hybrid and remote roles
12 Paid Holidays
Educational Assistance
Parental Leave and Adoption Assistance
Volunteering and charitable donation match programs
Diversity & Inclusion Programs
On-Site Child Daycare, Café, Fitness Center
Company
Olympus Corporation of the Americas
At Olympus, we put a lot of good back into the world, and what we do, really matters.
5,001-10,000 employees
H1B Sponsorship
Olympus Corporation of the Americas has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (4)
2022 (3)
2021 (3)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Abigail Hunter-Syed
Director
Lyne Charron-Keller
Executive Director, Global Marketing, Respiratory Business
Recent News
2023-10-25
Company data provided by crunchbase
