Manufacturing Engineer; 2nd Shift

Monday to Friday 1 PM‑10 PM.

The Manufacturing Engineer is responsible for supporting production lines and manufacturing processes for Liquid Silicone Rubber (LSR) molding operations. The role drives execution of molding technologies, improves efficiency, and ensures compliance with global quality and regulatory standards in the medical device industry. Collaboration with cross‑functional teams, vendors, and management to deliver high‑quality products while achieving cost and productivity targets is also required.

Process Optimization:

• Validate robust manufacturing processes for LSR molding.
• Drive revalidation activities for process / tool / equipment changes.
• Lead process improvement initiatives to enhance productivity, cycle time, and material utilization.
• Design experiments and analyze data to optimize process parameters, ensuring consistent product quality.
• Develop and implement control plans, process flow diagrams, and PFMEAs to mitigate risks.

Project Management:

• Serve as the technical lead in root cause investigations and implementing countermeasures.
• Coordinate with vendors and suppliers for equipment selection, procurement, and commissioning.
• Provide regular updates to stakeholders, including management, on project status and milestones.

Regulatory Compliance and Documentation:

• Ensure all processes meet ISO 13485 and FDA regulations for medical device manufacturing.
• Develop and maintain detailed documentation, including work instructions, validation protocols (IQ, OQ, PQ), and SOPs.
• Ensure compliance with electrical and regulatory requirements for North American and European markets.

Collaboration and Cross‑Functional Support:

• Partner with Quality, Manufacturing Engineering, and Production teams to resolve process challenges.
• Work with Design Engineering to provide feedback on part designs for manufacturability (DFM).

Innovation and Continuous Improvement:

• Research and integrate emerging technologies in LSR molding to improve efficiency and reduce waste.
• Lead initiatives for automation, such as robotic part handling and lights‑out manufacturing.

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering, Plastics Engineering, Manufacturing Engineering, or a related field.
• Minimum 3+ years of experience in Manufacturing Engineering (ideally with Injection Molding/LSR Manufacturing).
• Experience supporting production lines in 24x7 environments.
• Hands‑on experience with molding machines and robotic automation.
• Proven track record in leading and supporting engineering projects in highly collaborative environments.
• Strong knowledge of quality systems (ISO 13485, FDA regulations) and validation protocols.
• Proficient in CAD software (e.g., Solid Works) and data analysis tools (e.g., Minitab, JMP).

Preferred Qualifications:

• Master’s degree in engineering field.
• Familiarity with medical device manufacturing and associated regulatory requirements.
• Knowledge of process monitoring systems (e.g., RJG, Kistler).
• Six Sigma Green Belt or higher certification.
• Strong leadership and project management skills, with a PMP certification preferred.

• Analytical problem‑solving and decision‑making skills.
• Excellent communication and interpersonal abilities.
• Detail‑oriented with a strong commitment to quality and compliance.
• Ability to manage multiple priorities in a fast‑paced, dynamic environment.
• Team player with a proactive approach to innovation and continuous improvement.

• Comprehensive medical, vision, dental, and life insurance.
• AD&D, short‑term and long‑term disability insurance.
• Sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA).
• Commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP).
• Employee Assistance Program (EAP) and tuition assistance.
• Paid Time Off (PTO): fifteen days in the first year, 11 paid holidays, and 3 floating days.
• Primary caregiver leave (14 weeks) and secondary caregiver leave (2 weeks).

Res Med is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.