Senior Medical Device Packaging Engineer

Found in: Appcast Linkedin GBL C2 - 3 weeks ago

Grand Rapids, United States Planet Pharma Full time

This is a W2, at-will Contract starting 20-months with potential to extend or be hired on FTE at some point based on performance and business need. Benefits are available through Planet Pharma.


Location: On-site at Grand Rapids, MI

Hours: 40 hours per week

Product Line: Cardiac Surgery


Top 3 technical skills that you are required for this role:

  1. Experience in medical device packaging systems and packaging process validations IQ/OQ/PQ
  2. Advanced understanding of packaging requirements and standards I.E. ISO 11607-1 and 11607-2, ISO 13485
  3. Experience in CAPA, support, develop and execute remediation plans


Education Required: Bachelor of Science Degree in Packaging Science Mechanical Engineering or similar discipline


Years of Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering


Responsibilities may include the following and other duties may be assigned:

  • Designs develops and tests a wide variety of containers used for the protection display and handling of products.
  • Determines packaging specifications according to the nature of the product cost limitations legal requirements and the type of protection required considering need for resistance to such external variables as moisture corrosive chemicals temperature variations light heat rough handling and tampering.
  • Designs package exteriors considering such factors as product identification sales appeal aesthetic quality printing and production techniques.
  • Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices GMPs and may support prototype line development in manufacturing facilities/plants.


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 in-depth 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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