Process Development Engineer II
About The Position
A developing professional in this position will provide input to product development projects related to defining, characterizing, optimizing, and validating stable, robust, and capable processes for neuro-interventional medical devices. This position will analyze and identify opportunities for the improvement of internal equipment and processes. This role uses prior experience, learned engineering principles, critical thinking and creative problem-solving skills to evaluate processes and equipment performance. Collaborate with cross-functional teams to define, characterize, optimize, validate, document, and control manufacturing processes by identifying and measuring critical process parameters (CPP) that impact critical quality attributes (CQA) of a product. Perform process characterization studies to validate, improve, or establish processes or equipment to deliver a quality product consistently. Collect, analyze and interpret data to document equipment performance and process outputs. Define, develop, and qualify new equipment/fixtures or improve existing equipment/ fixtures. May participate in innovating, identifying, and selecting new process technologies.
Requirements
- Excellent analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP with strong ability to prioritize and provide creative, effective and practical solutions.
- Exceptional critical thinking skills with strong ability to intuitively identify problems, logically and empirically, and associate cause and effect under a variety of perspectives and constraints.
- Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards.
- Familiar with GMP, GDP procedures and requirements.
- Excellent project management and communications skills (both written and verbal).
- Ability to complete routine tasks independently and contribute to initiatives in a team setting.
Nice To Haves
- Professional experience in the medical device or related regulated industry is preferred.
Responsibilities
- Collaborate with cross-functional teams to define, characterize, optimize, validate, document, and control manufacturing processes by identifying and measuring critical process parameters (CPP) that impact critical quality attributes (CQA) of a product.
- Perform process characterization studies to validate, improve, or establish processes or equipment to deliver a quality product consistently.
- Collect, analyze and interpret data to document equipment performance and process outputs.
- Define, develop, and qualify new equipment/fixtures or improve existing equipment/ fixtures.
- May participate in innovating, identifying, and selecting new process technologies.
Benefits
- Employee Benefits include a stake in our collective success with stock options, bonus, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
