Job description
Thank you for your interest in positions at IPG Photonics. All Applicants must apply on our company website to be considered. Please click here to apply directly: https://recruiting.adp.com/srccar/public/RTI.home?c=2179707&d=ExternalCareerSite&r=5000901778006&_fromPublish=true#/
Description:
IPG’s Medical Products Group is focused on developing next-generation medical products based on IPG’s state-of-the-art lasers. The Medical Software Quality Engineer is responsible for maintaining and developing software used in the development and manufacture of medical lasers.
Duties:
Description:
IPG’s Medical Products Group is focused on developing next-generation medical products based on IPG’s state-of-the-art lasers. The Medical Software Quality Engineer is responsible for maintaining and developing software used in the development and manufacture of medical lasers.
Duties:
- Provide SW Quality Engineering support for the IPG Medical team during design, development and release to production phases of product development
- Provide support throughout the product SW lifecycle by participating in SW development reviews, code reviews and formal SW technical reviews
- Document SW specifications, verification/validation testing protocols, risk assessment & analysis, and cybersecurity in accordance with applicable medical device development standards
- Ensure SW development activities and deliverables meets the Quality and Regulatory requirements of FDA and ISO standards
- Participate in risk assessment activities
- Review and approve new and modified SW product designs for quality characteristics, testability and traceable to product requirements, including verification/validation test plans and results
- Review and ensure DHF compliance for all SW deliverables
- Represent SW Quality for IPG Medical group for internal design and review
- Support and interact with other departments, including R&D, technical support, field service, and manufacturing
Requirements
Qualifications:
Experience Desired:
- 5+ years of work experience in medical device Quality
- Professional certification such as ASQ, IEEE, Six Sigma, or LEAN manufacturing
- Strong working knowledge of IEC62304, ISO 13485, ISO 14971, and Cybersecurity regulations Proficient with the use of Microsoft Office Products (Word, Excel, PowerPoint, Visio, Project)
- Proficiency in creating and maintenance of software documentation for medical devices
Education Required:
- Bachelor's degree in a relevant engineering discipline (e.g. Biomedical, Electrical, Computer Science, or Software Engineering)
Personal Requirements:
- Strong oral, written and interpersonal skills required for interaction within group, with other departments and customers
- Attention to detail, results-oriented, with ability to multitask
- Aptitude to learn new systems and technologies
- Self-motivated and proactive
- English speaking with ability to read and write in English
Location(s)
225 Cedar Hill Road, Marlborough, Massachusetts 01752
Employment Type
Exempt
Equal Opportunity Employer / Affirmative Action M/F D/V
IPG Photonics Corporation is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. All employment decisions and personnel actions at IPG Photonics are administered without regard to race, color, religion, creed, national origin, ancestry, sex, age, qualified mental or physical disability, gender identity, sexual orientation, genetic carrier status, any veteran status, any military service, any application for any military service, or any other category or class protected by applicable federal, state or local laws. IPG Photonics Corporation provides reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974 and Title I of the Americans with Disabilities Act of 1990. Applicants who need accommodation in the job application process should contact (508) 506-2527 or email HR.Accommodations@ipgphotonics.com opens an email client application to request assistance. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.
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