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, recently named “Most Trusted Companies”, has an opening for a Design Assurance Engineer
What You Will Do: You will serve as Design Assurance core team member on all objectives related to specific identified business opportunities. You will be afforded the opportunity to use your expertise to lead and ensure relevant functional activities on a project team are completed to ensure successful and reliable new product development.
What You Will Learn: Spectranetics attracts and hires 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: You will have the opportunity to provide career growing results by:
- 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
- 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: None
Material and Equipment Directly Used:
- Spectranetics' Policies and Procedures
- FDA regulations and international standards
- Personal Computers
- BS Engineering or other Technical discipline, preferred
- CQE Certifications – ASQ desired
- Five to Ten years in medical device industry with a minimum of 2 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.