Spectranetics

Senior Design Quality Engineer

Spectranetics$103K — $143K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's/Master's Degree in Engineering or Science or equivalent
  • 5+ years of experience in quality, engineering, service, or manufacturing in a regulated environment
  • 2+ years of product design experience
  • Experience with FMEAs and Product Safety Risk Management
  • Expertise in Risk Management (IEC 14971), Medical Device Software Life Cycle (IEC 62304), and Usability Engineering (IEC 62366) is preferred

Responsibilities

  • Oversee system and hardware quality and safety risk management throughout the product life cycle
  • Provide independent oversight of design input, validation, and transfer processes
  • Ensure hardware design meets quality and compliance standards for project milestones
  • Conduct independent assessments of product quality performance
  • Analyze post-market product quality data for continuous improvement

Benefits

  • Generous PTO
  • 401k with up to 7% match
  • HSA with company contribution
  • Stock purchase plan
  • Education reimbursement
Full Job Description
Job Title
Senior Design Quality Engineer

Job Description

In this role you

Will be part of a team that is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We're looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality-of-life billions for the billions of people Philips brand touches each year.

Your role:
  • Accountable for oversight of system and hardware quality and safety risk management throughout the product life cycle.
  • A Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
  • Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
  • Performs independent technical assessment on product quality performance and post-market product quality analysis


You're the right fit if:
  • Bachelor's / Master's Degree in Engineering or Science or equivalent.
  • 5+ years of experience, 2+ years of experience in product design as demonstrated by a role in quality, engineering, service, or manufacturing in a regulated environment with Medical Device experience.
  • Experience with FMEAs and Product Safety Risk Management
  • Expertise in Application of Risk Management to Medical Devices (IEC 14971), Medical Device Software Life Cycle Processes (IEC 62304), and Application of Usability Engineering to Medical Devices (IEC 62366), 21CFR820 are pluses.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.


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.

Philips Transparency Details

The pay range for this position in Bothell WA is $103,000 to $143,000 Annually.

The pay range for this position in Cambridge MA is $103,000 to $143,000 Annually

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 Bothell WA or Cambridge MA.

#LI-PHI

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

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