What are the responsibilities and job description for the Sr Process Engineer position at Medical Engineering Consultants (MEC)?
Sr Process Engineer - Exempt
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Education Required: Bachelor's degree in engineering, science, or a related discipline
Years’ Experience Required: Minimum of 4 years
Top 3 Technical Skills Required
Responsibilities
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Education Required: Bachelor's degree in engineering, science, or a related discipline
Years’ Experience Required: Minimum of 4 years
Top 3 Technical Skills Required
- Process Development including characterization, process, and equipment qualification validation activities.
- Problem-solving – demonstrated ability to resolve production issues.
- Manufacturing and quality experience – able to partner with operations and quality to develop manufacturing methods and work instructions.
Responsibilities
- Development of device processing, assembly, and packaging methods for assigned product lines.
- Proactively execute and support validation/qualifications activities (e.g., IQ, OQ, PQ, Characterization).
- Partner with Quality Engineering to ensure proper process compliance, including quality documentation (e.g., work instructions, quality system reports).
- Partner with Quality during risk management activities and may lead and/or actively participate in risk management document reviews (e.g., Design and Process Failure Mode and Effects Analysis).
- Resolve technical production problems on assigned product lines in finishing, assembly, and packaging operations, working with shop employees and quality personnel.
- Collaborate cross-functionally to develop new line layout and infrastructure to support assigned products. May make recommendations to management on plant layout and implement manufacturing equipment acquisitions.
- Work with equipment suppliers on equipment specifications, quoting of specified equipment, and delivery schedules.
- Initiate and direct improvements in current manufacturing methods and processes to improve quality performance, process efficiency, and reduce manufacturing costs.
- May lead in the training of direct and indirect team members.
- Ensure processes and procedures are in compliance with regulations (21 CFR 820) and Quality Systems.
- Provide periodic updates of assigned projects to senior management, maintain project documentation, project plans, action item registers, and actively manage risks related to cost, quality, and schedule.
- Bachelor's degree in engineering, science, or a related discipline with a minimum of 4 years relevant experience.
- Experience in Process Development including characterization, process, and equipment qualification and validation activities.
- Experience in quality documentation activities within highly regulated environments.
- Excellent communication skills, both written and verbal.
- Ability to collaborate cross-functionally.
- Medical device industry experience.
- Experience in Design Transfer.
- Experience supporting various equipment including testing firmware or software loading and related processes.
- Experience working with Manufacturing Execution Systems.
- DRM and/or Lean Six Sigma Certification.
- Sponsorship is not available for this position
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
