Manufacturing Process Engineer

Company Name:
Medela
This position is responsible for establishing, modifying, validating and implementing manufacturing processes to maximize quality, efficiency, throughput and waste elimination with minimal supervision and direction. Directly reporting to the Operations Engineering Manager, interfaces and supports Manufacturing, Quality and Engineering teams in the completion of continuous improvement initiatives. Performs a variety of software and equipment development tasks to ensure compliance with Medela Quality Management System policies, procedures, standards and similar directives from regulatory agencies and governing bodies pertaining to medical device manufacturing (e.g. ISO 13485 and FDA 21 CFR Part 11)
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to these items:
Ensure timely completion of assigned tactical projects in support of strategic imperatives
Lead the development and maintenance of electronic device history records, work instructions, batch records, equipment logs, material specifications and other documents
Create, develop, revise and execute validation protocols to assess performance and validity of software, hardware, tooling, fixtures and equipment in compliance with quality and regulatory requirements; provide direction and support to Validation Technician
Collect, document and analyze performance metrics of validation runs and process development projects; complete and submit validation reports in a timely manner
Monitor production areas on a regular basis to provide engineering support in identifying, troubleshooting and resolving process failures, scrap generation & equipment downtime
Implement process improvements using all available data, including customer returns, production floor rejects, warranty data and customer service call information
Provide engineering support to kaizen events, NCR resolution and CAPA initiatives
Develop, review and approve manufacturing documentation, and provide training to production, quality, technical and supervisory personnel
Support Medelas conformance to ISO, FDA, and other regulatory standards
Develop, implement and complete cost improvement and avoidance projects
Provide general support to Operations, Engineering, Sourcing and Quality teams
Maintain full understanding of company policies, procedures, and safety practices
All Employees are responsible for regular and reliable attendance, learning and complying with all safety and health rules and regulations for their work areas. This included but is not limited to: Reporting all incidents and injuries; Supporting the Company in providing a safe place to work; Protecting yourself, co-workers and equipment from damage or injury; Cooperating and assisting in incident investigations; Using all appropriate personal protective gear; Practicing sanitary health habits; Following emergency procedures and instructions as needed.
SUPERVISORY RESPONSIBILITIES
This job has no supervisory responsibilities.
QUALIFICATIONS
Qualifications that represent the knowledge, skill and/or ability required by this position are listed below. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelors degree (BS) in engineering or 12 years work experience in related field required
Minimum five years of experience in process engineering and manufacturing environment:
o Process development, validation, verification and qualification (IQ/OQ/PQ)
o Process capability, PFMEA, SPC, GR&R and other quality tools
o Data-gathering and analysis, troubleshooting and problem solving
o ProE, SolidWorks, CAD or equivalent software
o Lean manufacturing and six sigma tools application
Ability to manage multiple projects and priorities simultaneously to timely completion
Strong computer skills required (e.g. MS Office, Project, Minitab, LabView)
Hands-on automated/semi-automated design, operation and optimization skills
Strong communications and interpersonal skills required
Ability to operate in fast-paced, results and team-oriented manufacturing environment
Effectively lead and work in teams to develop and implement sustainable solutions
Software validation is preferred
Medical device manufacturing experience is strongly preferred

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