Spectranetics

Product Safety Quality Engineer

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

Qualifications

  • 2+ years experience with Bachelor's or relevant experience with Master's in relevant fields; preferred 5+ years.
  • Strong knowledge of relevant regulations and standards such as ISO 13485 and IEC 62304.
  • Expertise in risk management activities including FMEA, DFQ, and root cause analysis methods.
  • Ability to meet minimum physical, cognitive, and environmental job requirements.
  • Excellent communication skills to influence cross-functional stakeholders.

Responsibilities

  • Evaluate product designs to identify safety concerns and hazards.
  • Apply advanced assessment tools like FMEA and FTA in evaluations.
  • Conduct thorough reviews of documentation related to product safety.
  • Identify and document risks impacting reliability and compliance.
  • Utilize systematic methodologies to analyze safety issues in hospital monitoring products.

Benefits

  • Generous Paid Time Off (PTO).
  • 401k plan with up to 7% company match.
  • Health Savings Account (HSA) with company contributions.
  • Stock purchase plan available.
  • Education reimbursement for continued learning.
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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