|
QUALIFICATIONS
|
|
|
|
|
Required:
|
- Bachelor’s Degree in Mechanical, Industrial, Biomedical, or related Engineering from an accredited university; or education/experience equivalent
- A minimum of 6 years of manufacturing engineering (equipment/process design and support) in a regulated industry such as Medical Device, Pharmaceutical, or food; OR a master’s degree in related field plus 4 years’ experience
Preferred:
|
- Experience with medical device manufacturing (heat staking, ultrasonic welding, press assembly, adhesives, leak testing) and inspection technologies (vision systems. Pressure decay, flow testing)
- Experience programming vision systems, robotics, and PLC
- Experience designing and implementing high-volume manufacturing equipment preferred, i.e., production 1M+ annual, cycle time < 3 seconds per process
- Six Sigma Yellow/ Green Belt Certification
|
|
Skills & Competencies:
|
- Ability to effectively create 3D engineering models, assemblies, fixtures, and drawings (Solidworks preferred)
- Ability to create experimental designs and collect, interpret, and analyze data using statistical techniques (Minitab preferred)
- Strong technical writing skills (planning, protocol writing, execution, report writing, Operating Procedures)
- Knowledge of PLC and HMI programming for equipment troubleshooting or minor modifications (Allen Bradley preferred)
- Strong understanding and application of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation (FAT, SAT, IOQ, OQ, PQ, PPQ)
- Must be able to work effectively on electrical, mechanical, and/or software related issues associated with equipment
- Strong analytical and creative problem-solving skills, able to provide solutions to complex technical challenges
- Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)
- Communicate effectively through both verbal presentation and technical writing to various internal stakeholders of varying technical abilities
- Demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives.
- Demonstrated technical coaching and leadership of peers
- Strong demonstrated ability to deliver manufacturing projects in a timely manner
Physical Requirements:
- Must be able to remain in a stationary position for extended periods of time
- Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
- Ability to work within, around, and potentially underneath equipment for extended periods of time
|
|
RESPONSIBILITIES:
|
- Manufacturing equipment specification, design, development, construction, implementation, or modification
- Troubleshoot and implement solutions to aid in the manufacture of the product. Typical solutions require changes to assembly equipment and/or the modification of part/mold design and inspection criteria to improve the quality, reproducibility, efficiency or safety of the manufacturing processes
- Assist in Equipment Qualification (installation, operational and process qualifications (IQ/OQ/PQ)) to meet regulatory requirements
- Standard Operating Procedures creation, revision and implementation including necessary change order, training and qualification activities
- Apply engineering principles and methods to understand and provide solutions to complex technical challenges
- Identify and coordinate activities with outside suppliers and consultants as required. Interface with and select suitable vendors for the procurement of equipment
- Provide DFM and DFA guidance for development of robust product design in collaboration with Product Development
- Develop test methods and fixtures to prove functionality of sub-assemblies and final product. Select appropriate test methods and analyze test data to challenge the effectiveness of assembly equipment and processes
- Prepare overall project proposals including cost estimates and schedule for designated projects. Assign priority and schedule tasks to provide timely solutions to achieve results
- Resolve internal and external (customer or supplier) issues related to manufacturability and performance of product
- Maintain and repair equipment
- Delegate tasks to technicians and co-ops within the department
- Participate in cross functional teams and ideation sessions
- Work with functional managers and partners to ensure project goals are met
- Provide technical guidance and coaching of other engineers
- Contributes to project planning and execution to meet schedule and budget requirements
- Author Quality System documentation to support all of the responsibilities above, including but not limited to change control, engineering change orders, equipment forms, calibration forms, and preventive maintenance forms
|
