Website LanceSoft Inc
LanceSoft Inc
Company : LanceSoft Inc
This position will work in a team environment at Mounds View site supporting product and materials development with a focus on released products. 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 includes 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, are also included.
Day-to-Day Responsibilities
- 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 as needed.
- Communicate results and strategies via detailed technical documents and presentations.
- Support the quality and reliability of released products 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.
Required Skills
- Materials Characterization of Metallic, Ceramic, or Polymeric Components
- Mechanics of Materials
- Assessment of Materials of Concern
- Fatigue testing
Qualifications
- 1 year of relevant experience with a bachelor's degree in material science, metallurgy, ceramics, or a 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).
Additional Responsibilities
Responsibilities may include the following and other duties may be assigned:
- Analyze, research, design, and develop 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.
- Apply principles of chemistry, physics, and material behavior to develop metallic, nonmetallic, and composite material and processing specifications, fabrication, and assembly processes.
- Develop, analyze, and apply 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 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 a 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 the effectiveness of the 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 decision-making.
- Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.
- Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.