Are you looking for an opportunity to apply your technical skills to develop state-of-the-art medical devices? Would you enjoy developing clinical tools to improve patients' lives? Do you have a drive to contribute, learn, and be an integral member of a high-performance research and development team?
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 R&D Engineer.
What You Will Do: Working alongside experienced engineers, you will be a contributing member of a technical team developing new, innovative medical products. Your tasks will include: mechanical design of selected product elements; design documentation creation and management; and test protocol development, execution, and data analysis. You will perform your duties as an integral member of a multi-functional team working to develop all aspects of the new product in a highly collaborative environment.
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 all facets of state of the art medical device development. You will be exposed to clinical leaders to understand the needs behind the products you help to develop.
What You Will Become: A capable technical teammate with an understanding of relevant clinical needs, and experience developing new medical devices to meet those needs.
What Success Looks Like:
A solid technical understanding of mechanical systems and the basic toolset for mechanical design
Designs new product or changes to existing product given specific input requirements and constraints
Generates design documentation such as CAD models, drawings, BOM, test protocols, test reports, Engineering Change Orders, assembly instructions
Produces prototypes for evaluation, development, and test, which may include assembly and limited machining
Works with vendors on component design and fabrication
Generates invention disclosures for new design concepts
Develops and executes engineering studies, analyzes data, provides recommendations
Working understanding of electrical and mechanical systems
Strong Design Control and documentation skills
Ability to read and understand drawings, schematics, and data
CAD proficiency in creating both solid models and finished drawings – SolidWorks preferred
Ability to develop test protocols, conduct hands-on testing, analyze the data, and write test reports
Planning, developing, and executing system level verification and validation testing
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
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
Supervisory Duties: None
Material and Equipment Directly Used:
Computers with applicable software packages; SolidWorks, Microsoft Office, Microsoft Project, Microsoft Power Point, et al.
Test data analysis software packages; JMP, Minitab
Four year degree in Engineering or Physics or equivalent skills and experience – BS in Mechanical Engineering preferred
Demonstrated communications skills to enable effective contribution as a member of a multi-functional team is essential
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)
Experience with medical devices and/or laser systems 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.