Planet Pharma
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The individual in this position will 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 product. 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 decision making.
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.
Sr Materials Engineer
8200 Coral Sea Street Northeast Saint Paul, MN 55112 US
Posted: 09/14/2023
2023-09-14
2023-10-22
Employment Type:
Contract
Job Category: Engineering
Job Number: 581841
Is job remote?: No
Country: United States
Job Description
- Can you please confirm your top 3 skills sets required?
- 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)
- Experience in a regulated industry
- What is your target years of experience?
- Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
The individual in this position will 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 product. 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 decision making.
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.
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