Development Engineer I
Are you an innovative senior level new product development expert with a passion for the medical device industry? Do you thrive in leading the technical process and have a passion for driving innovative product concepts to launch? Do you have a successful track record under your belt in the design and development of vascular catheters?
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 a Development Engineer I in our Maple Grove location.
What You Will Do: You will be conducting detailed design and testing of new products and processes under development, and ensuring that product designs and processes meet specifications. Activities include new product idea development and documentation, prototyping, product specification development, test method and process development, and test protocol and report writing.
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 vascular intervention procedures. Our leaders are focused on supporting your continued growth and we will expand your capabilities to help further our organization's ability to innovate, manufacture, acquire, and commercialize medical devices for Vascular Intervention procedures.
What You Will Become: A highly skilled engineer who will be key in shaping new product development and execution for high impact results helping achieve our mission of delivering products and services that are consistently safe and effective, and consistently compliant to strict quality and regulatory requirements.
What Success Looks Like:
- You will build prototypes, perform testing, analyze results, and present results in design reviews
- Support development of customer and product requirements, establishing design and process plans, protocols, and reports, and applying engineering principles to understand, improve, and control product performance
- Assist in developing risk/failure mode assessment, test method development, process development, and performance and safety testing for vascular intervention medical devices
- Support translation of high-level objectives into detailed technical plans, lead execution of the plan, and update the cross-functional project team on key technical and timeline risks
- Maintain required documentation and write technical reports, prepare engineering drawings with specifications and tolerances, transfer technology to process development and manufacturing engineering
- Assist in preparing timelines, cost analyses, and resource needs
- Completely and accurately document project data
- Comply with applicable FDA, international regulatory laws/standards, and the Code of Conduct
Supervisory Duties: None
Material and Equipment Directly Used:
- Spectranetics' Policies and Procedures
- FDA regulations, international regulations, and international standards
- Personal Computers
- Various types of test equipment, microscopes, and analytical instruments
- Experience with Solidworks, ACAD, MS Project, DOE software, statistics is desired
- Bachelor's degree in Mechanical, Chemical, Materials, or Biomedical Engineering or similar field with 0-3 years direct experience
- Proven skills in device or process design and project completion
- Medical interventional device development experience is desired
- Computer skills to include spreadsheets and word processing
- Good verbal and written communication skills
- Intern / co-op experience in the design and processing of medical products desired; prior experience with devices for vascular intervention a bonus
- Working knowledge of GMP and ISO regulations a bonus
- Self-motivated, team-oriented professional with good interpersonal and 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.