Description

You will own manufacturing engineering functions within a regulated environment.

This role is on-site.

Responsibilities

• Coordinate and support suppliers for manufacturing custom equipment and tooling.
• Develop and execute IQ and OQ protocols and reports.
• Generate and issue SOPs and manufacturing procedures for approval.
• Develop manufacturing capacity analysis and process characterizations using DOE.
• Develop documentation and justification for assigned capital projects.

Required Skills

• 5+ years of experience in Manufacturing, New Product Transfers, or Product/Process Development.
• Experience in the Medical Device or Pharmaceutical Industries.
• Knowledge of cGMP, ISO, EHS, and Statistical regulations.
• Proficiency in technical writing and generating SOPs.
• Experience with Qualification/Validation (IQ/OQ/PQ) and Gage R&R.
• Familiarity with Design of Experiments (DOE) and Process Characterization.
• Strong computer skills in Word, Excel, and PowerPoint.
• Knowledge of MS Project.
• Bilingual proficiency in English and Spanish (written and oral).

Preferred Skills

• Lean / Six sigma Training or Certification.
• Project Management Training or Certification.

Key Skills

Education

Bachelor's degree