Planet Pharma
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Additional detail provided by manager:
This role will be part of a large process development team (10+) that will develop optimized processes for a new production line that will produce a well established medical device catheter product. This is a mostly on-site role with occasional hybrid (remote) work possible as allowed and/or needed by the project.
Must Have
Nice To Have
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.
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.
Sr Manufacturing Engineer (Sr. Process Development Eng)
2300 Berkshire Lane North Minneapolis, MN 55441 US
Posted: 06/06/2023
2023-06-06
2023-07-07
Employment Type:
Contract
Job Category: Engineering
Job Number: 564013
Is job remote?: No
Country: United States
Job Description
Additional detail provided by manager:
- Can you please confirm your top 3 skills sets required? Sense of urgency, process development (optimization & validation), fixture design
- What is your target years of experience? 5+ years
- When do you plan to start interviewing? Mid to late May
- Will you be looking to hire and start ASAP or will the start date be delayed? ASAP, but it’s critical to get the right person
- Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Mostly onsite but with some flexibility
This role will be part of a large process development team (10+) that will develop optimized processes for a new production line that will produce a well established medical device catheter product. This is a mostly on-site role with occasional hybrid (remote) work possible as allowed and/or needed by the project.
Must Have
- Automation
- Communication Skills
- design of experiments
- Medical Device
- new product development experience
- PFMEA
- positive teamwork and leadership traits
- process capability
- process development/optimization
- process validation
- Root Cause Analysis
- self-starter
- Sense of Urgency
- Test Method Validation
- Tool/fixture design
Nice To Have
- adhesives
- braiding
- catheter experience
- catheter reflow
- chemical dip process experience
- DRM knowledge and experience
- equipment development experience
- experience with the logistics of devices built at multiple sites
- hands-on development experience
- laser welding (SS to SS)
- metals processing
- nitinol forming and heat-set experience
- operator ergonomics
- poka-yoke (error proofing)
- polymer thermal bonding
- production experience
- sewing
- swaging
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.
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.
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