Actalent Process Engineer in Chelmsford, Massachusetts
• Evaluate process development & validation deliverables for portfolio products for compliance to current quality system requirements
• As needed, plan and guide the execution of Process and Equipment Characterization and Validation activities to remediate gaps in legacy product portfolios to meet current quality system requirements
• Working with Project Management, establish project timelines, track progress, manage to the schedule and communicate project status to management and project leader. Manage tasks and deliverables for multiple projects simultaneously
• Evaluate equipment, tooling, fixtures and component materials for their ability to produce product per design specifications and compliance to the quality system.
• Evaluate process characterization and investigations for documentation of key process inputs and outputs and to verify that appropriate process limits have been established
• Conduct test data analyses including identification of outliers or non-normal data, generating data plots, general statistical analysis, and determination of process capability.
SPECIALIZED SKILLS & OTHER REQUIREMENTS:
• Experienced in process qualification and validation activities including risk assessment, range finding, DOE and creation of process documentation
• Proficiency in process validation (IQ, OQ & PQ), experience with various production processing methods and the product/process development cycle
• Proficiency in MS Office applications, strong written and verbal communication skills, ability to read and understand technical drawings, product requirements and specification documents
• Must have strong independent problem-solving skills and have sufficient understanding of statistical techniques to perform data analyses and process capability analyses (familiarity with statistical software such as Minitab preferred)
• Excellent analytical and problem solving skills, experience with scientific methods and Design of Experiments.
• Preferred: 5 years of experience in medical device production or product development.
• Preferred: Experience with common disposable medical device manufacturing processes (e.g. molding, reflow, coating, bonding, packaging).
Additional Skills & Qualifications:
• Bachelor in Engineering or physical sciences required
• 2 years of related experience required
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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