Manufacturing Engineer III

Job Title: Manufacturing Engineer III
Location: On-Site - Plainsboro Township, NJ 08536
Work Hours: 8:30 AM to 5:00 PM (Flexible)

Position Overview:

We are seeking a highly skilled Manufacturing Engineer III to join our team. This position requires a proactive, communicative, and detail-oriented individual to support remediation efforts for EU MDR technical files, provide engineering and project management expertise for manufacturing process improvements, and collaborate with cross-functional teams on complex projects. The ideal candidate will have strong technical report-writing skills, experience with change controls, and the ability to work effectively in a team environment.

Top 3 Skills Required:

1. Ability to prepare and execute complex technical reports, project summaries, and correspondence.
2. Experience with change controls, particularly labeling or packaging changes.
3. Excellent communication skills with the ability to work well in a team environment.

Essential Duties & Responsibilities:

• Assist in the remediation of identified gaps related to operations and packaging for EU MDR technical files from an engineering perspective.
• Provide process engineering and project management support for remediation projects, ensuring the correct design and implementation of manufacturing processes to mitigate risks.
• Generate all necessary documentation, drawings, and specifications in compliance with procedures and regulatory requirements (US FDA and ISO).
• Coordinate specific project tasks, including the development of manufacturing process requirements, specifications, validations, Engineering Change Orders (ECOs), and Engineering Drawings.
• Implement statistical process control where necessary, and analyze process parameters to improve manufacturing yields, reduce scrap, and error-proof processes.
• Conduct technical investigations and provide practical solutions under appropriate regulatory guidelines for Medical Device Manufacture. This includes Non-Conformance Investigations and Corrective and Preventive Action(s) (CAPA) support.
• Collaborate with technical teams from various departments (Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs) to meet project and product requirements.
• Apply problem-solving techniques to identify issues, assess their impact, and develop resolution plans.
• Contribute to manufacturing process development, including process design, risk analysis, and regulatory documentation such as design history files.
• Provide technical input for analyzing process and equipment changes, and lead the selection and design of manufacturing equipment as needed.
• Perform other tasks as assigned by management.

Desired Minimum Qualifications:

• Bachelor's degree in Engineering (Mechanical, Pharmaceutical, Chemical, Biomedical Engineering or related discipline).
• 3+ years of experience in manufacturing engineering within the medical device industry.
• Solid understanding of Quality System Regulation (QSR), Design Control, Process Validation guidelines, Engineering Change Controls, ISO standards, and regulatory requirements.
• Proficient in Statistical Process Control tools (SPC, Minitab, or similar software).
• Strong knowledge of chemistry, processing, and material expertise in manufacturing environments.
• Proven ability to prepare complex technical reports, project summaries, and correspondence.
• Exceptional problem-solving, organizational, and communication skills.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Job ID#511106