Project Engineer

This role combines hands-on process optimization and continuous improvement with project management responsibilities for capacity expansion new technology introduction equipment implementation and major improvement initiatives. The objective of the role is to improve manufacturing efficiency yield quality and scalability while ensuring robust validated and compliant processes and technologies are successfully delivered to operations.

Essential Functions & Accountabilities:

Process Engineering & Continuous Improvement

• Develop optimize and standardize manufacturing processes operating procedures and work instructions to improve efficiency yield quality and cost.
• Draft and evaluate process improvement ideas aligned with operational and business objectives.
• Perform risk assessments (e.g. FMEA) and support mitigation planning.
• Execute optimization trials data analysis and statistical process monitoring.
• Apply Lean Six Sigma and process excellence tools to drive sustainable improvements.
• Assist in or lead structured problem-solving for complex manufacturing and process issues.

Project & Technology Integration

• Define plan and manage engineering projects related to capacity expansion major continuous improvement initiatives and new technology or equipment introduction.
• Develop project charters objectives scope timelines and budgets; manage projects to successful completion.
• Lead and coordinate cross-functional cross-departmental and intercompany project teams including external vendors and subject matter experts.
• Support or lead vendor selection specification development and technical evaluation of new equipment and processes.
• Work with vendors to refine functional and technical specifications ensuring operations and process engineering requirements are met.
• Support or lead factory acceptance testing (FAT) site acceptance testing (SAT) installation and commissioning activities.
• Support or lead equipment and process validation activities in line with regulatory and internal standards.
• Provide post-validation support during production ramp-up ensuring stable and effective process transfer to operations.

Documentation Validation & Compliance

• Develop specifications validation protocols and reports associated with processes and equipment.
• Ensure project activities and process changes are documented in accordance with ISO 13485 FDA 21 CFR Part 820 and internal/global standards.
• Monitor and report manufacturing and project performance metrics; present progress and results to management.

Training & Support

• Provide technical guidance training and support to process engineering manufacturing and operations personnel on new or improved processes and equipment.
• Support best-practice sharing and alignment across facilities

Travel:
May be required to travel as needed up to an estimated 10%.

Knowledge Skills and Abilities:

• Strong knowledge and experience in a regulated medical device manufacturing environment (ISO 13485 and/or FDA 21 CFR Part 820).
• Solid understanding of process design and development equipment automation installation and validation.
• Strong project management skills with experience managing multi-disciplinary and multi-site teams.
• Experience with statistical process control data analysis and process monitoring.
• Practical experience with Lean Six Sigma and continuous improvement methodologies.
• Technical competence in automation and engineering tools (e.g. PLCs 3D CAD/SolidWorks instrumentation and sensing technologies) is an advantage.
• Excellent communication interpersonal and stakeholder management skills with the ability to influence and motivate peers and management.
• Ability to guide direct and support manufacturing and engineering personnel in both operational and project environments.
• Minimum 35 years of engineering experience with a focus on process optimization automation and/or equipment implementation in a manufacturing environment.
• Proven experience managing engineering or technical projects preferably within the medical devices industry.
• Education: Bachelors degree in Mechanical Engineering Manufacturing Engineering or a related engineering discipline.

Work Environment:

• Manufacturing environment and Office environment
  Workshop/May include exposure to dust heat or cold
  Prolonged periods of computer-based work