Spectranetics

Product Safety Quality Engineer

Spectranetics$92K — $146K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 2+ years experience with a Bachelor's or some experience with a Master's in relevant fields; 5+ years preferred.
  • Strong knowledge of medical device regulations and standards (ISO 13485, ISO 14971, IEC 62304, IEC 82304).
  • Proficiency in risk management techniques like FMEA and root cause analysis.
  • Excellent communication skills for influencing cross-functional stakeholders.
  • Ability to meet specific physical, cognitive, and environmental job requirements.

Responsibilities

  • Evaluate product designs to identify safety concerns and hazards.
  • Apply risk assessment tools such as FMEA and FTA in evaluations.
  • Perform comprehensive reviews to ensure safety standards are met.
  • Identify and document risks affecting reliability and compliance.
  • Utilize methodologies to analyze and mitigate safety issues associated with patient monitoring products.

Benefits

  • Generous paid time off (PTO).
  • 401k plan with up to 7% employer match.
  • Health Savings Account (HSA) with company contribution.
  • Stock purchase plan offering opportunities for employees.
  • Education reimbursement for professional development.
Full Job Description
Job Title
Product Safety Quality Engineer

Job Description

Product Safety Quality Engineer, Hospital Patient Monitoring

The Product Safety Quality Engineer ensures that safety and compliance documentation is thorough, accurate, and aligned with regulatory standards and internal policies, all while working independently. This role rigorously assesses complex product designs using advanced analytical tools and risk assessment methods like FMEA and FTA to uncover safety insights and address challenging reliability issues.

Your role:

  • Evaluates product designs to uncover safety concerns and potential hazards.
  • Applies advanced risk assessment tools, including Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA), during the assessment process.
  • Perform comprehensive reviews to ensure product safety is thoroughly addressed.
  • Identifies and documents risks that could impact reliability and compliance.
  • Uses systematic methodologies to analyze and mitigate potential safety issues in hospital patient monitoring products.

You're the right fit if:

  • You’ve acquired 2+ years of experience with Bachelor’s OR some experience with Master’s in areas such as DFMEA’s, product quality, and risk management analysis and documentation activities in the medical device industry; 5+ years strongly preferred.
  • Your skills include a strong knowledge of relevant regulations and standards (ISO 13485, 14971; IEC 62304, 82304, etc.); strong knowledge of FMEA’s, and risk management related activities, Design for Quality (DFQ), and root cause analysis methods.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
  • You’re an excellent communicator, with an ability to influence cross-functional stakeholders utilizing your technical expertise and knowledge of risk management best practices.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office-based role.

The pay range for this position in Orlando, FL and Murrysville, PA is $92,000 to $146,000.

The pay range for this position in Cambridge, MA is $103,000 to $163,000.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.   

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.  Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.  Details about our benefits can be found . 

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. 

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position.  For this position, you must reside in or within commuting distance to posted locations.

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About Spectranetics

Spectranetics is a medical device company that develops, manufactures, and markets single-use medical devices used in minimally invasive procedures within the cardiovascular system. The company's products include laser atherectomy systems, thrombectomy systems, and lead management accessories. Spectranetics was founded in 1984 and is headquartered in Colorado Springs, Colorado. In 2017, the company was acquired by Royal Philips for $2.2 billion.
Learn more about Spectranetics
Size
900 employees
Industry
Founded
1980

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