SUMMARY (PRIMARY FUNCTIONS): The Senior Manufacturing Engineer is responsible for collaborating with and managing Key Contractors involved in design, manufacture, test, and product fulfillment activities required for the development, transfer to manufacturing, and commercialization of Sterifre Medical Inc. products.
PHYSICAL GUIDELINES: (This position does not require lifting of more than 30 lbs.)
INTERNAL AND EXTERNAL CUSTOMER CONTACT: This position requires excellent rapport with internal and external customers. Consistent, timely, documented communication with vendors and consultants to ensure deliverables are being met. Direct interface and communication with Sterifre staff in particular management groups as required.
- Collaborate with Contract Design House and Contract Manufacturers. Ensure Sterifre Medical’s requirements are understood and agreed-upon deliverables are completed according to established project schedules.
- Evaluate new suppliers and monitor current suppliers for compliance to Sterifre Medical’s requirements.
- Review and provide input to creation of and changes to specifications and drawings.
- Provide input for risk analyses and risk management activities.
- Develop or assist in development of test methods and protocols required for design verification and validation. Review and draft, as required, final reports.
- Co-lead with contract design house and contract manufacturers in design reviews and project phase-end reviews.
- Lead in developing inspection and test processes for components, subassemblies, and finished devices.
- Assist in troubleshooting and failure investigations of complaint products, as required.
- Support maintenance of Sterifre Medical’s quality management system through creating and revising Standard Operating Procedures and work instructions.
- Perform other duties as required.
Qualifications and Knowledge:
- Design and development controls (ISO 13485 and FDA Quality System Regulations).
- Production and process controls (ISO 13485 and FDA Quality System Regulations).
- Quality management systems (ISO 13485 and FDA Quality System Regulations) and relevant standards and regulations.
- Wide range of types of manufacturing processes (i.e., machining, injection molding, blow molding, coating methods, mechanical and electrical assembly, etc.)
- Test and monitoring equipment.
- Software-controlled systems.
- Design of experiments.
- Verification and Validation testing.
- Skill in mechanical drawings and use of CAD software.
- Experience in use of project management software (Microsoft Project preferred).
- Written and verbal communication, including procedure, protocol and report writing.
- General statistics and applications.
- Risk analysis and reliability engineering techniques.
- State of the art manufacturing process.
- Identify requirements, setting realistic scheduling and meeting deadlines.
- Identify issues, problem solving, determining root cause and implementing solutions.
- Ensure compliance to standards and regulations and company procedures.
- Travel up to 60% (expected) of the time to contract manufacturer during initial design development and transfer to production.
- Handle multiple projects simultaneously.
- Communicate well verbally and in writing – present to a wide range of audiences.
- Effectively manage vendors and lead program efforts with contract design houses, contract manufacturers, and critical suppliers.
- Apply engineering principles to methodically solve technical challenges.
- Evaluate current and novel technologies, products, and services.
- Maintain accurate written records and documentation.
Education: Bachelor and/or Master of Science degree in an engineering discipline
Experience: Minimum of five years in medical device or regulated development and manufacturing environment. Previous manufacturing engineer position(s) with extensive experience in managing contract design house and contract manufacturers with transition from development to production and on to commercialization preferred.