Process Engineer II

POSTED: February 26, 2019
BUSINESS: Cook Biotech, Inc.
POSITION TYPE: Full-time
START DATE: Immediate Availability

Responsibility

  • Lead and contribute to process improvement/creation via error-proofing, addressing root cause, eliminating non value added activities, and identifying/appropriately elevating process constraints
  • Contribute to development and implementation of advanced manufacturing solutions as agreed upon by key stakeholders.
  • Lead and contribute to risk analyses as needed to support regulatory requirements and quality system activities.
  • Lead and contribute to process validations and re-validations in a timely manner, and according to quality system requirements.
  • Qualify equipment, tools, and instruments (ETI).
  • Write specifications and instructions. Evolve writing ability.
  • Generate technical drawings of ETI. Evolve drawing ability.
  • Procure or produce jigs and fixtures for projects as needed.

Knowledge

  • Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties.
  • Use and demonstrate competence with continuous improvement tools (e.g. 5S, value stream mapping, theory of constraints, kaizen).
  • Seek new skills/knowledge relevant to CBI. 

Decision-Making

  • Gather the facts and communicate them to key stakeholders.
  • Propose solutions and decisions.
  • Consult management for key decisions.

Collaboration

  • Listen to ideas from production, colleagues, and management.
  • Communicate effectively with production, colleagues, and management.
  • Provide training on process improvements.

Change/Innovation

  • Relentlessly eliminate waste from processes by evolving the CBI quality system.

Communication

  • Understand and demonstrate requirements for writing and documenting in the medical device industry.
  • Understand and demonstrate best-practices for presenting information.

Other

  • Conduct other corporate duties when required.

MINIMUM WORK EXPERIENCE / EDUCATIONAL REQUIREMENTS:

  • BS in engineering or related field, or equivalent experience
  • At least 2-5 years of experience in engineering or related field
  • Able to set goals for self and work to achieve milestones
  • Able to work effectively on multiple projects simultaneously
  • Able to understand and apply basic statistics
  • Able to create and interpret basic technical drawings
  • Able to operate CAD software such as Creo
  • Able to operate statistical software such as JMP
  • Able to effectively communicate with others
  • Good record keeping and documentation skills
  • Interest in working directly in a manufacturing environment
  • Willing to work with material derived from animal tissues
  • Sufficient background to generally understand medical and biotechnology terminology

PHYSICAL REQUIREMENTS / WORK ENVIRONMENT:

  • Must be able to perform the essential functions of the job, with or without reasonable accommodations
  • Limited exposure to hazardous chemicals used in the manufacture of the product.
  • Physical demands are typical of an office and classroom environment.

EMPLOYEE REQUIREMENTS:

Sign non-competition and confidentiality agreements. Compliance with all policies of the company including without limitation the COOK Employee Manual, COOK Code of Conduct, COOK Electronic Information Policy, HIPAA regulations, and COOK Policy & Guidance on Interaction with Healthcare Professionals.

This job description in no way states or implies that these are the only duties to be performed. This position is expected to follow other job related instructions and duties.

APPLICATION INSTRUCTIONS:

Interested candidates please send cover letter and resume to Jordan@cookbiotech.com.

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