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 products with drug coating?
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 Staff Development Engineer in our Maple Grove Location.
What You Will Do: You will be managing research and development activities from concept stage of PDP projects through commercialization. You will lead detailed design and testing of new products and processes under development, ensuring that product designs and processes meet specifications, and identifying and recommending solutions for complex technical issues. Activities include new product idea development and proper documentation, prototyping, product specification development, test method and process development, test protocol and report writing, and facilitating technical team meetings regarding these topics.
You will also as a technical lead on development projects, assisting the Program Manager in creating the project schedule, ensuring that technical tasks performed by engineers on the project team are executed on time and in compliance with the design and development plan, conducting technical team meetings, coordinating the activities of R&D engineers as well as cross-functional resources.
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 influential leader who will be key in shaping new 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 Looks Like:
Create ideas for new products that meet marketing and product design specification requirements
Manage research and development activities from Concept Phase through Commercialization.
Coordinate and/or participate in events that provide clinical feedback and guidance, such as physician interface meetings and animal studies
Develop engineering drawings for product components and subassemblies that meet marketing and product design specification requirements
Establish test methods, acceptance criteria, and test equipment for all stages of product development
Establish clinically relevant bench and animal testing models
Provide technical leadership on process design, from high-level technical strategy to detailed production system documentation
Write protocols and reports for process characterization and validation testing
Develop manufacturing processes for products, subassemblies, and/or components
Manage tasks, review and approve work conducted by R&D engineers and technicians to meet project timelines
Manage work conducted by outside vendors and ensure work product conforms to Design Control or other applicable SPNC SOPs
Select and qualify raw materials and potential vendors
Plan, coordinate, and execute animal studies
Compile Design History File
Ensure that development activities are documented through lab notebook, history file, and other records
Solve complex problems where analysis of situations or data requires an evaluation of intangible variance factors
Provide independent judgment in developing methods, techniques, and evaluation criteria for product related research and development
Provide technical guidance and mentorship to engineers
Supervisory Duties: May supervise technical staff (Engineers or technicians)
Material and Equipment Directly Used:
Spectranetics' Policies and Procedures
FDA regulations and international standards
Experience with Solidworks, ACAD, MS Project, DOE software, statistics is required
S. / B.Eng. in a relevant science or engineering discipline or equivalent work experience. M.S. / M. Eng. Preferred.
A minimum of 8 years working in the medical device field
Knowledge of design/process controls
Experience writing product requirements, specifications, test protocols, and test reports
Understanding of device testing in both in vitro and in vivo environments
Basic knowledge of solid modeling software such as SolidWorks, advanced knowledge preferred
Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
Exercise compliance to all medical device regulations and best business practices
Up to 20% travel
Must be able to access a controlled environment room
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.