Are you looking for an opportunity to apply your proven test and reliability engineering skills to develop complex, state-of-the-art medical laser equipment? Are you a seasoned subject matter expert in verification, validation, and reliability testing for new product development? Do you have a proven ability to collaborate with customers, multi-disciplinary teammates, and development partners to deliver successful new products to market?
If your answer is yes, then we may be looking for you!
Spectranetics, recently named “Most Trusted Companies”, has an opening for a Senior R&D Engineer.
What You Will Do: You will serve as our R&D teammate, providing subject matter expertise in design for testability and reliability for electro-mechanical systems for new laser medical equipment and catheter development projects. You will own formal verification and validation activities including planning, protocol development, execution, and report generation. You will also manage the incorporation of design for reliability and the reliability test strategy for new products.
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 ndustry 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 laser systems and disposable products.
What You Will Become: A highly influential subject matter expert who will be responsible for verification and validation for Spectranetics products.
What Success Looks Like:
Required technical skills include:
Proven “concept to commerce” development of electromechanical capital equipment in a highly regulated environment (medical preferred)
Strong design control and documentation skills
Experience in evaluating a design for testability
Planning, developing, and executing system level verification and validation testing
Creating and executing component and system level reliability test procedures, troubleshooting, and system level analysis (e.g. accelerated life testing, HALT/HASS)
Experience in design for reliability for mechanical, digital/analog circuit, and electro-mechanical system reliability analysis highly desired
Desired leadership skills include:
Serving as expert to project teams on verification, validation, and reliability engineering
Experience in supporting project management in the development of project plans including schedules, resourcing, budgeting
Appropriate escalation of cross-functional support issues on projects to the Project Manager or to functional leadership as appropriate
Proven ability to actively evaluate project for opportunities to improve performance; continuously monitors risk and mitigates as appropriate
Identify opportunities and continuously improve internal engineering test and reliability best practices
Building key relationships with customers relating to their project(s)
Approving project expenses to a given amount level
Required teambuilding and personnel management skills include:
Demonstrated drive for results
Passion for learning and continuous improvement
Excellent written and verbal communication abilities
Desire to help craft an environment in which all team members are respected regardless of their individual differences based on consistently demonstrated personal values
Supervisory Duties: No direct reports
Material and Equipment Directly Used:
Computers with applicable software packages (e.g. Microsoft Office, Microsoft Project, Microsoft Power Point, etc.)
Test data analysis software packages (JMP, Minitab, ReliaSoft)
Minimum four year degree in applicable engineering field; Mechanical, Electrical, BioMedical
Minimum of 6 years' combined experience in product development
Experience in a regulated industry required (medical device development experience along with a solid working knowledge of FDA Quality System Regulations and ISO 13485, and ISO 60601 is preferred)
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.