Validation and Manufacturing Specialist
4 days ago
About the Job:
The Senior Manufacturing Process Engineer will be responsible for developing and implementing new manufacturing processes, ensuring that they meet the highest quality standards. This includes validating manufacturing processes, leading manufacturing line trials, and managing quality assurance and procedures.
Main Responsibilities:
- Process Development: Develop and implement new manufacturing processes to improve efficiency and reduce costs.
- Process Validation: Assist in validating manufacturing processes to ensure product specifications and standards are achieved.
- Manufacturing Line Trials: Lead manufacturing line trials for new products and processes, ensuring seamless integration and minimal downtime.
- Quality Assurance: Manage quality assurance and procedures by testing and validating systems and parts, and establishing new validation standards and procedures.
- Trial Preparation: Ensure part availability, line readiness, and pre-requisite data obtained and consolidated prior to trials.
- Trial Report: Document observations, analysis, and results, making recommendations as needed and driving solutions. Record all issues found during trials and help drive to closure.
- Trial Recovery: Ensure manufacturing lines are validated and/or restored to prior condition post-trials. Evaluate the success of each trial, considering yield, downtime, cost, capacity, safety, and other key metrics.
- SME Expertise: Serve as a subject matter expert on trials, ensuring proper validation procedures are followed.
- Cross-Functional Collaboration: Collaborate with cross-functional teams to evaluate the best processes for rollout.
- Tracking and Reporting: Track all trial details in PCA tracking system for approvals and provide regular updates to stakeholders.
- Change Control Leadership: Lead and provide feedback in change control meetings.
Requirements:
- Bachelor's degree in Mechanical, Electrical, or Manufacturing Engineering, or equivalent working experience.
- 5+ years' experience in a manufacturing environment; experience with semi-automated manufacturing equipment is a plus.
- Understanding of manufacturability, process design, process validation, and assembly methods, with an aptitude to learn and incorporate new technologies.
- Experience breaking down high-level performance issues into addressable action items, identifying issues, and making corrective measures to resolve.
- Skillful with electrical and computer-based tools, including precision measuring equipment, electrical test equipment, and computer databases.
- Understands and appropriately applies principles, procedures, requirements, and policies related to specialized projects.
- Proven ability to operate under pressure with rigid time constraints, track and manage multiple tasks simultaneously, and work in a fast-paced environment, occasionally requiring extended hours.
- Ability to work closely with cross-functional departments, communicate effectively across cultures and geographic regions, and possess excellent written and verbal skills.
Compensation:
Expected annual salary range: $71,400 - $107,100, plus cash and stock awards, and comprehensive benefits package, including medical, dental, vision, 401(k), and more. Pay offered may vary depending on individualized factors, including market location, job-related knowledge, skills, and experience.
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