Process Development Engineer II

Main Responsibilities

• Develop and optimize manufacturing processes for medical devices, focusing on performance, quality, efficiency, and compliance with regulatory standards.
• Create and implement manufacturing process IMV (Inspection Method Validation), TMV (Test Method Validation), IQ (Installation Qualification), OQ (Operational Qualification), and PPQ (Process Performance Qualification) activities.
• Drive continuous improvement initiatives to enhance product quality, reduce manufacturing costs, and increase productivity through data analysis, root cause analysis, and the implementation of corrective actions.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure seamless integration of new processes into production.
• Design and develop automation solutions and jig fixtures to streamline manufacturing processes and reduce manual intervention.
• Oversee the implementation of automated processes, ensuring compliance with safety standards and regulatory requirements.
• Prepare and execute validation protocols, including developing testing procedures, data analysis, and generating validation reports.
• Conduct risk assessments and contribute to risk management activities related to the manufacturing process.
• Create and maintain comprehensive documentation, such as work instructions, standard operating procedures (SOPs), and process flowcharts, in accordance with regulatory guidelines and Good Manufacturing Practices (GMP).
• Ensure all processes and manufacturing activities adhere to Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
• Collaborate with the Quality Assurance team to address any compliance issues and implement corrective actions.
• Work closely with the R&D team to provide manufacturing inputs during product development, ensuring manufacturability and scalability of new designs.
• Collaborate with the Manufacturing team to transfer new processes into production and provide ongoing support for process-related issues.

Basic Requirements

• Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related).
• Minimum of 2 years of experience in Process Development and Manufacturing Engineering within the medical device industry.
• Knowledge and experience in validation processes (IMV-TMV-IQ-OQ-PPQ) and documentation practices in a regulated environment.

Preferred Qualifications

• Familiarity with jig fixture automation and process automation techniques.
• Understanding of Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
• Excellent problem-solving skills and the ability to apply engineering principles to improve processes and solve technical challenges.
• Strong communication and interpersonal skills, with the ability to work effectively in cross-functional teams.

Pay

Target base salary range: $92,000 – $112,000, plus eligibility for an annual short-term incentive (STI) targeted at 7% of base salary and equity participation. Final compensation will be determined based on experience and alignment with role requirements.

Benefits

• Medical, Dental, and Vision Plans
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Equity Program
• Paid Holidays & Vacation
• Employee Assistance Program