Are you an innovative Senior Level Quality Assurance Leader with a passion for the Medical Device industry? Do you thrive in team environments, developing product quality improvements, and quality system compliance? Do you enjoy product risk management and test method development?
If your answer is yes, then we may be looking for you!
Spectranetics, now a part of Philips Image Guided Therapy Devices, has an opening for a Senior or Principal Design Assurance Engineer.
What You Will Do: You will serve as a core team member completing relevant Design Assurance activities on new product development projects, which help ensure our overall project and business objectives. Your primary role will revolve around device risk management, test method development and validation, design verification planning and testing as well as quality system compliance.
What You Will Learn: We attract and hire the best talent on the planet! You will be working with a great team of dedicated experts and leaders in the Medical Device Industry who will support your continued growth. You will learn from our Engineers, Clinicians, Sales Leaders, and other industry professionals about our state of the art products.
What You Will Become: A highly influential leader who will be key in shaping product development and execution for high impact results helping achieve our mission of delivering consistently high quality, safe and effective, regulatory compliant products and services.
What Success Looks Like:
Participating in product development functions by fulfilling a core team role and implementing quality engineering tools and documentation that ensure quality objectives are achieved
Determining and recommending test methods, sampling plans, equipment requirements, measurement techniques and training requirements that will assure specific quality levels on your projects
Reviewing and providing recommendations on test plans and protocols
Coordinating Design Verification planning and testing
Providing guidance for statistical rationales and analysis during Design Verification and Validation
Providing guidance for navigating regulations and other regulatory requirements
Improving quality system processes to develop robust and reliable designs
Assisting with effective and value added Design Reviews
Utilizing risk management to ensure safe and reliable product designs and processes
Unfailing commitment to the safety of Spectranetics' customers and patients
Supervisory Duties: May supervise junior Engineers, Technicians, or interns, as necessary.
Material and Equipment Directly Used:
Spectranetics' Policies and Procedures
FDA regulations and international standards
BS Engineering or other Technical discipline, preferred
CQE Certifications – ASQ desired
Five to ten years in medical device industry with a minimum of 4 years in a senior capacity in quality engineering/design assurance function
Agencies that submit a resume to SPNC must have a current executed SPNC Agency Agreement executed by a member of the Talent Acquisitions Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a SPNC Recruiter. All resumes must be submitted to the vendor portal under these terms or they will not be considered.
This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required.
This job description is subject to change as the needs and requirements of the department and business change.
All applicants must pass a pre-employment drug screen to be hired.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or status as an individual with a disability.
BS Engineering or other Technical discipline, preferred CQE Certifications ASQ desired Five to ten years in medical device industry with a minimum of 4 years in a senior capacity in quality engineering/design assurance function