TÜV SÜD America Inc., a global leader in product safety, regulatory affairs and certification, has an immediate opening at our headquarters in Peabody, Massachusetts for a:
Product Specialist (Test Engineer) Medical Devices
Product Specialist (Test Engineer), under the supervision of the Program Manager, is responsible for the assessment of medical devices and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related customer and project management. The Product Specialist, as part of a team, serves as liaison between the customer and the company in order to plan and execute projects, and to support the client in questions regarding regulatory and standard requirements.
With direction, performs and documents product safety reviews for active and active implantable medical devices in accordance with regulatory and standard requirements (in particular regarding AIMD 90/385/EEC Annex 2 Clause 4, MDD 93/42/EEC Annex II
- Conducts and documents on and off site product testing to determine compliance with applicable international standards and regulations in accordance with CB, NRTL,SCC and AIMD 90/385/EEC, MDD 93/42/EEC,
- Represents the test laboratory in any quality audits, Maintains the medical device test laboratory quality system
compliance through procedures development and editing as required.
- Performs constructional reviews,
- Keeps abreast of present and future product safety requirements, test procedures, instrumentation, technology and company engineering service capabilities by internal training sessions, external seminars and reading of technical articles,
- Coordinates and performs NRTL Factory Inspections as appropriate
The minimum requirements of the position of Product Specialist/Test Engineer include a Bachelor’s degree in engineering or related field, or foreign degree equivalent, plus at least one year of experience in product safety testing in medical device industry.
Why should you join TÜV SÜD America?
- A competitive compensation package that includes health & dental insurance
- 401(k) retirement savings plan with matching contributions
- Paid Time off for volunteering in the community
- Wellness Programs:
- Fitness and Weight Loss Reimbursement through our Health Plan
- Additional rewards for leading a healthy lifestyle
- Flu Clinics
- Health & Wellness Education
- Walking Clubs
- Employee Assistance Program - a program of services that provides assistance to employees and
families with balancing the demands of work and home.
- Corporate sponsored running and walking events
- Company sponsored outings and holiday events
- Opportunities to expand your career internationally and work alongside people from diverse cultures and
- Develop and grow in a performance-based environment that recognizes and rewards top performers
- Continuous training and learning opportunities to support the professional and personal development of
- Work alongside experts and market leaders in a company with a strong recognizable brand worldwide
- Make a positive contribution to change and progress; doing your part to ensure safety, quality
and environmental sustainability
We look forward to hearing from you! Click on Apply Now button for quick and easy aplication process guidelines.
Or, if you prefer, please email your resume and cover letter, clearly stating the position you are applying for, to:
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TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation,
gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of