Product Life Cycle Engineer I

POSTED: May 31, 2018
BUSINESS: Cook Biotech Inc.
POSITION TYPE: Full-time - Exempt
START DATE: Immediate Availability

PRIMARY FUNCTION:

The person in this position has responsibility for supporting products life cycle management to existing products and other related duties as determined by the CBI Quality System

ESSENTIAL JOB FUNCTIONS / DUTIES:

  • Perform risk analysis updates with guidance from engineering, mentor or supervisor.
  • Review complaints analysis and document effect on risk profile.
  • Update risk management reports and conduct residual risk review.
  • Perform Type-1 design changes as required.
  • Conduct updates to design traceability matrix as per guidance from engineers and supervisor / mentor when required.
  • Assist engineering in mitigating product life-cycle data deficiency 
  • Conduct testing as needed.
  • Work as a team member on individual and multi-member team projects.
  • Communicate project status, hurdles to project lead or mentor/supervisor.
  • Remain current and apply the understanding of FDA-ISO
  • 13485 and quality system requirements in carrying out duties.
  • Remain current and apply the understanding of ISO 14971.
  • Conduct other corporate duties when required.

MINIMUM WORK EXPERIENCE / EDUCATIONAL REQUIREMENTS:

COOK Biotech, Inc. shall have sufficient personnel with the necessary education, background, training, and experience to assure all functions and duties are correctly performed.

  • Bachelor of Science in engineering or related field.
  • Good writing skills equivalent to medium level laboratory reporting.
  • Able to work independently and on teams
  • Good task management skills and able to work on multiple tasks simultaneously.
  • Able to effectively listen to ideas and concerns coming from experienced engineers and other CBI stake holders and incorporate suggestions appropriately. 
  • Able to effectively communicate task status to stake holders.
  • Good record keeping and documentation skills.
  • Willing to work on documentation and writing heavy tasks.
  • Willing to work with material derived from animal tissues
  • Sufficient background to generally understand medical and biotechnology terminology.
  • Ability conduct bench tests

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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