Search Jobs
Sr Materials Engineer
8200 Coral Sea Street Northeast Mounds View, MN 55112 US
Job Description
- Knowledge of materials and interactions with the body and environment and ability to correlate material properties with product performance to predict various failure modes
- Knowledge of international and domestic regulations associated with Materials of Concern, Biocompatibility and Hazardous Substances ((e.g. RoHS, EU MDR, California Prop. 65, ISO 10993)
- Knowledge and experience of Materials Characterization Techniques
Can you please confirm the 3 main responsibilities/day to day activities required for this role?
- Assembling current design documentation, providing gap assessments and strategies to demonstrate compliance in accordance with international standards and global Materials of Concern medical device regulations (e.g. RoHS, EU MDR, California Prop. 65).
- Performing Materials Characterization
- Collaboration with other functions
What products (if any) will this role support? Will be working on most of the CRM /CAS/MCS products
What is your target years of experience? See below -
Engineer II: Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years relevant experience
Senior: Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with 2 years relevent experience
The individual in this position will work on assessement of changes likes manufacturing, supplier, and regulations on the materials properties, compliance to the regulations and the performance of the impacted products. It involves develop and execute the Materials of Concern and hazardous substances analysis of medical device products, supporting the regulatory submission of both implantable and non-implantable products. This person will work under general supervision, assembling current design documentation, providing gap assessments and strategies to demonstrate compliance in accordance with international standards and global Materials of Concern medical device regulations (e.g. RoHS, EU MDR, California Prop. 65). 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: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.
Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management.
Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Mounds View, MN
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.