Spectranetics

Product Safety Engineer

Spectranetics$102K — $163K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years of experience in product safety and compliance for medical devices
  • Proficient in IEC 60601 and ISO 80601 safety standards
  • Bachelor's degree in Electrical, Mechanical, Biomedical Engineering or similar; Master's preferred
  • Ability to meet physical and cognitive job requirements
  • Effective communicator with stakeholders at various levels

Responsibilities

  • Lead and manage product safety and compliance activities for medical devices
  • Serve as the subject matter expert on IEC 60601 standards
  • Plan and execute product safety testing and certification
  • Support audits and maintain laboratory process documentation
  • Collaborate with cross-functional teams to address product safety challenges

Benefits

  • Generous PTO policy
  • 401k with up to 7% company match
  • Health Savings Account with company contributions
  • Employee stock purchase plan
  • Education reimbursement opportunities
Full Job Description
Job Title
Product Safety Engineer

Job Description

Product Safety Engineer (New Kensington, PA)

Lead product safety and compliance efforts that help bring innovative Sleep & Respiratory Care technologies to patients around the world.

Your role:
  • Lead product safety and compliance activities for medical devices, helping ensure products meet regulatory requirements and internal quality standards throughout the product lifecycle. You will support safety testing, risk assessments, and compliance decision-making for complex medical technologies
  • Serve as a product safety subject matter expert by interpreting and applying International Electrotechnical Commission (IEC) 60601 standards to product designs. You will partner closely with engineering teams to provide guidance, evaluate compliance requirements, and recommend design solutions.
  • Plan, execute, and oversee product safety testing and certification activities for a portfolio of respiratory care products. This includes working with external testing and certification organizations to support timely approvals and ongoing compliance.
  • Support audits, inspections, and accreditation activities while helping maintain and improve laboratory processes, procedures, and documentation. You will also monitor evolving regulations and standards and assess their impact on current and future products.
  • Collaborate with engineering, quality, regulatory, manufacturing, and external partners to solve complex product safety challenges and drive continuous improvement. This is an onsite lab-support role based in Pittsburgh, where regular in-person collaboration is expected.


You're the right fit if:
  • You've acquired 5+ years of experience supporting product safety, compliance, and certification activities for medical devices in a regulated environment. Experience with product safety testing and working with certification organizations is highly valued.
  • Your skills include interpreting and applying medical device safety standards, including International Electrotechnical Commission (IEC) 60601 and International Organization for Standardization (ISO) 80601 requirements. Bonus skills include experience with electromagnetic compatibility testing, wireless compliance requirements, respiratory medical devices, or Artificial Intelligence tools and technologies.
  • You have a Bachelor's degree in Electrical, Mechanical, Biomedical, or another Engineering discipline; a Master's degree is preferred.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
  • You're an independent and collaborative professional who communicates effectively with a variety of stakeholders and is comfortable influencing decisions related to product safety and compliance. You demonstrate initiative, ownership, and accountability while thriving in a highly technical environment.


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 role.

The pay range for this position in New Kensington, PA is $102,000 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 here.

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 New Kensington, PA

#ConnectedCare

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

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

Similar Jobs

More Jobs at Spectranetics

More Healthcare Jobs

Find similar Product Safety Engineer jobs: