Senior Core Products Engineer

POSTED:  May 25, 2018
BUSINESS: Cook Biotech Inc.
POSITION TYPE: Full-time-Exempt
START DATE: Immediate Availability

PRIMARY FUNCTION:

The person in this position has responsibility for driving continuous process improvement and quality related to manufacturing of core products. This may include process improvement, process validation and other related duties as determined by the CBI Quality System.

ESSENTIAL JOB FUNCTIONS / DUTIES:

  • Drive manufacturing quality and efficiency by leading and managing projects that: improve processes and/or design by error-proofing, address root cause, eliminate non-value add activities, identify and appropriately elevate process constraints
  • Demonstrate and teach effective use of continuous improvement tools (e.g. 5S, value stream mapping, theory of constraints, kaizen) to CBI teams.
  • Relentlessly eliminate waste from processes by evolving the CBI quality system.
  • Seek out, lead, develop and implement advanced manufacturing solutions as agreed-upon by key stakeholders.
  • Conduct risk analyses and sustaining engineering activities for Core Products as-needed to support Regulatory or other quality system activities.
  • Conduct process validations and re-validations in a timely manner and according to quality system requirements.
  • Ensure process validations for Core Products are consistently relevant, appropriately implemented and documented.
  • Select, qualify and improve production equipment, tools and instruments with the goal of preventing defects, designing for manufacturability and improving quality.
  • Write specifications and instructions.
  • Coordinate and/or provide training on process improvements to production personnel.
  • Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties.
  • Conduct other corporate duties when required.

MINIMAL WORK EXPERIENCE / EDUCATIONAL REQUIREMENTS:

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

  • BS in engineering or related field
  • At least five (5) years previous experience in engineering and a manufacturing environment
  • Able to work independently and in interdepartmental teams
  • Good project management skills and able to work on multiple projects  simultaneously
  • Able to effectively listen to ideas and concerns coming from Production personnel
  • Able to effectively communicate ideas to others
  • Good record keeping and documentation skills
  • Willing to work with material derived from animal tissues
  • Sufficient background to generally understand medical and biotechnology terminology.
  • Ability to make prototypes and 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.

APPLICATIONS INSTRUCTIONS:

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

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