Job Description
This position will work in a team environment at the Mounds View site supporting product and materials development with a focus on released product. The candidate will be part of a team ensuring product safety and reliability through the direction and execution of characterization testing and assessment as well as assessment of changes impacting materials. This will include providing problem solving, materials laboratory testing and data analysis in support of new and existing implantable biomedical devices and systems. Biocompatibility, Materials of Concern, and biostability testing, as well as documenting product equivalence through appropriate characterization testing will also be included.
Additional responsibilities include providing materials engineering support to document product compliance with international biocompatibility and supporting regulatory submission. Primary areas of focus include testing for materials reliability, stability, and compliance to other regional standards for medical devices.
This person will work under general supervision, solving technical problems in cardiac therapy with an emphasis on materials and materials analysis.
A Day in A Life
·Conduct laboratory testing and write technical reports to document device/component compliance with necessary regulations and materials characterization requirements.
·Work in a regulated environment.
·Support regulatory submissions with technical rationales/documentation on an as needed basis.
·Communicate results and strategies via detailed technical documents and presentations.
·Support the quality and reliability of released product through comparative testing or root cause characterization testing.
·Participate in the analysis of technical issues and the development of recommendations for project decisions and actions
·Possesses experience in the following business-critical skill sets:
o Materials Characterization of Metallic, Ceramic, or Polymeric Components
o Mechanics of Materials
o Assessment of Materials of Concern
o Fatigue testing
·Maintains a focus on quality, possesses the necessary drive and determination to promote the highest level of customer satisfaction, quality, reliability, performance, cost, and development predictability.
·Contributes to the design of new products or processes based on business strategy.
Qualifications
·1+ years of relevant experience with a bachelor’s degree in material science, metallurgy, ceramics or related field
·Advanced Degree with little/no experience welcomed
Preferred Qualifications
·Experience in materials with the ability to identify testing methods to correlate material properties with product performance.
·Experience in manufacturing and/or development.
·Working knowledge of multiple classes of engineering materials: metals, polycrystalline, and single crystal ceramics, glasses, and polymeric materials.
·Experience performing failure analysis
·Demonstrated ability to deliver quality technical work within project schedules and timelines.
·Knowledge of regulations related to Biocompatibility, Materials of Concern, and Hazardous Substances (e.g. RoHS, EU MDR, California Prop. 65, ISO 10993)
·Knowledge of statistical methods and Design of Experiments (DoE) using Minitab.
·Knowledge of Microsoft applications (Excel, Word, Outlook).
Responsibilities may include the following and other duties may be assigned. Analyzes, researches, designs and develops materials and their related fabrication and application processes to develop and optimize materials for use in engineering design of and/or application in structures, systems and subsystems. Applies principles of chemistry, physics, and material behavior to develop metallic, nonmetallic and composite material and processing specifications, fabrication and assembly processes. Develops, analyzes and applies material properties and design allowables, processing processes and quality engineering specifications. Material analyses may include failure analysis of components, systems and subsystems, life predictions, and definition and requirement specifications. May review and approve subcontractor material processing procedures.
SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
DIFFERENTIATING FACTORS
Autonomy:
Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact:
Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
Innovation and Complexity:
Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence:
Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience:
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Job Tags
Contract work, For subcontractor,