Are you a highly organized new product development engineer with experience in balloon catheter manufacturing or design? Do you thrive in facilitating the communication between technical teams and the manufacturing team to get a new product to launch? Do you have a successful track record of owning a project and being independent to complete it?
If your answer is yes, and you pursue everything with energy, drive,and a need to succeed,then we may be looking for you!
Spectranetics is searching for an R&D Engineer II in our Fremont North Location.
What You Will Do: You will be a key driver to conduct the design and process development of our medical devices. You will be responsible for the validation, project transfer, and support of commercial launch activities for SPNC's vascular catheter products.
What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with an incredible team of dedicated experts and leaders who will be developing the next standard of care for Peripheral and Coronary procedures. Leaders focused on supporting your continued growth.We will expand your capabilities to help further our organization's ability to innovate, manufacture, acquire, and commercialize medical devices for Vascular Intervention and Cardiovascular procedures.
What You Will Become: A highly influential driver who will support ournew product development and execution for high impact results helping achieve our mission of delivering consistent high quality, safe and effective, regulatory compliant products and services.
What Success LooksLike:
Develop and execute design/process characterization, design verification, and design and/or process validation plans, protocols, and reports.
Write testing plans, protocols and reports
Help prepare experimental plans and timelines, execute plans/experiments, and report progress to plan to core engineering team.
Understand, use, and complete engineering drawings with specifications and tolerances
Effectively transfer designs and processes to manufacturing engineering at product launch
Work effectively in a cross-functional collaborative team environment
Perform job functions in accordance with applicable GMP and ISO standards
Comply with applicable FDA and International Regulatory laws/standards and the Spectranetics Code of Conduct
Bachelor's degree in Chemical, Materials, Biomedical Engineering, or related technical field; Graduate degree in a technical discipline preferred
3 - 5 years of applicable work experience in an engineering role
Experience with vascular catheter products, processing and technologies
Combination Medical Device experience preferred,
Proficient in Design/Use/Process FMECA
Application of statistical and analytical methods such as SPC, SQC, and DOE
Process background (development, capability, optimization, validation) within a regulated industry and/or design development experience.
Test method development, protocols, execution, and report writing.
Good verbal and written communication skills
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.