Product Development Engineer
1 day ago
Olympus Corporation of the Americas is a subsidiary of Olympus Corporation, headquartered in Tokyo, Japan. We employ over 31,000 employees worldwide in nearly 40 countries and regions. Our Medical business is committed to delivering innovative solutions that improve patient outcomes and reduce healthcare costs.
SalaryThe estimated salary range for this position is based on national averages and may vary depending on location and qualifications.
Job DescriptionWe are seeking a highly skilled Product Quality Engineer to join our team in Westborough, Massachusetts. This role involves designing, developing, and managing projects for legacy products, ensuring compliance with company policies and medical device regulations.
The ideal candidate will have a strong background in quality engineering, experience working in an FDA-regulated environment, and excellent technical problem-solving skills using Six Sigma tools.
Required Skills and Qualifications- Bachelor's Degree in Engineering required.
- Minimum of 5 years of experience in Quality Engineering within an FDA-regulated medical device manufacturing environment.
- Strong working knowledge of technical problem solving via Six Sigma type tools to analyze, drive root cause, and solve problems.
- Proven track record in Sustaining Engineering, support of commercialized products, and Post Market Surveillance.
- Strong working knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
- Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, ISO 11135, EUMDR, and Human Factors.
Olympus offers a competitive compensation package, including:
- Base salary: $95,665.00 - $129,148.00 per year.
- Annual bonus (subject to plan eligibility and other requirements).
- 401(k) with company match.
- Comprehensive Medical, Dental, Vision coverage effective on start date.
- Employee Assistance Program.
- Wellness programs.
- Hybrid and remote work options.
- Paid time off.
- Educational assistance.
- Parental leave and adoption assistance.
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