Project Engineer

• Design and Development
  • Produce and implement product and process designs that meet performance, quality, and regulatory requirements.
  • Design, develop, test, and modify products, components, equipment, and devices to support new and existing product lines.
  • Create test procedures, fixtures, and protocols to support product characterization, experimentation, validation, and production activities.
  • Undertake relevant research and apply engineering principles to support innovation and continuous improvement.
• Testing, Analysis, and Documentation
  • Analyze and interpret engineering and test data to support product performance evaluation and decision-making.
  • Develop and document procedures for sub-assembly and final product inspection and testing.
  • Implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
  • Conduct first-article inspections and establish appropriate incoming inspection methods and criteria.
  • Design or specify inspection and testing mechanisms and equipment; perform statistical analysis to assess nonconformance and determine root cause and corrective actions.
  • Draft and maintain quality assurance documentation and technical reports, including Corrective and Preventive Actions (CAPAs), Non-Conformance Reports (NCRs), complaint trending and analysis, and Clinical Evaluation Reports (CERs).
  • Ensure all documentation and reporting follow Good Documentation Practices (GDP) and company quality policies.
• Manufacturing and Equipment Support
  • Support device manufacturing and production by troubleshooting, improving, and maintaining processes and equipment.
  • Maintain and implement new manufacturing-related equipment to enhance production efficiency and quality.
  • Maintain calibration and preventive maintenance schedules for production tools and equipment to ensure accuracy and reliability.
• Quality, Collaboration, and Compliance
  • Collaborate closely with Engineering, Quality, and Manufacturing functions to ensure quality standards and compliance requirements are met.
  • Assure proper documentation and traceability of all technical data generated for assigned projects in alignment with engineering policies and procedures.
  • Contribute to quality system improvements and initiatives that drive consistency, reliability, and regulatory compliance.
  • May specialize in areas such as design, incoming material inspection, production control, product evaluation and reliability, inventory control, or research and development as they relate to product and process quality.
• Additional Duties
  • Perform other related duties as assigned to support departmental and organizational objectives.

• Education
  • Bachelor’s Degree in Engineering (Mechanical, Biomedical, Chemical, or related discipline preferred).
  • Additional coursework or training in chemistry, materials science, manufacturing, or quality systems is a plus.
• Experience
  • Previous research, co-op, internship, or industry experience in an engineering or manufacturing environment required; preference for experience in the medical device industry or other regulated manufacturing setting.
  • Familiarity with ISO 13485, MDSAP, and MDD quality management systems and regulatory frameworks preferred.
  • Experience working in or supporting laboratory or production environments, including wet lab techniques (e.g., titrations, dilutions, sample preparation).
  • Knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and general lab safety procedures.
• Skills and Competencies
  • Strong communication skills, including the ability to clearly convey technical information in written reports, verbal discussions, and electronic correspondence.
  • Ability to communicate effectively with both internal team members and external partners, including through telephone, email, and in-person meetings.
  • Comfortable making formal presentations to small or large groups, including cross-functional teams or leadership.
  • Proven problem-solving and analytical skills, with the ability to identify issues, evaluate options, and implement practical solutions.
  • Proficiency in standard software applications, including Microsoft Word, Excel, PowerPoint, and other data analysis or documentation tools.
  • Ability to work independently and collaboratively, manage multiple priorities, and maintain accuracy and attention to detail in a fast-paced environment.

• Regularly required to sit, stand, and walk for extended periods.
• Must be able to lift, carry, and move materials or equipment up to approximately 25 pounds.
• Occasional bending, stooping, or reaching may be required when working with equipment or materials.
• Frequent use of hands, fingers, and fine motor skills to operate computers, tools, instruments, and test equipment.
• Visual acuity required for reading technical documents, operating equipment, and performing detailed inspection or testing tasks.
• May require the use of personal protective equipment (PPE) such as safety glasses, gloves, or lab coats when working in lab or production areas.

• Hybrid work schedule with a mix of office-based and on-site/laboratory/manufacturing floor activities.
• Office environment includes standard computer and communication equipment.
• On-site work may involve exposure to manufacturing equipment, chemicals, and controlled environments where safety and cleanliness protocols must be followed.
• Work may occasionally require flexibility in hours to support production schedules, testing, or project deadlines.
• Collaboration with cross-functional teams in both in-person and virtual settings.
• The role requires adherence to all environmental, health, and safety (EHS) standards and company policies.

• Comprehensive Health Coverage: Medical, dental, and vision insurance for you and your dependents.
• Time Off: Generous PTO policy and paid holidays
• Retirement Plans: 401(k) with company matching to help you plan for the future.
• Wellness Support: Mental health resources and wellness programs.
• Team Connection: Regular team events, retreats, and gatherings to build community.

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