| Location: Onsite Status Type: Full Time QUALIFICATIONS Required: - Bachelor’s Degree in Mechanical, Industrial, Biomedical, or related Engineering from an accredited university
- A minimum of 8 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 6 years’ experience
- A minimum of 1 year of FDA validation experience for equipment qualification and process validation
Preferred: - Experience with medical device manufacturing and inspection technologies (heat staking, manual assembly, discrete manufacturing, ultrasonic/laser welding, press assembly, adhesives, leak testing, vision systems, and robotics, preferred)
- Experience in a high-volume manufacturing environment preferred, i.e. production 1M+ annual, cycle time < 7 second.
- Six Sigma Black Belt (CSSBB) or Lean Six Sigma Certification
Skills & Competencies: - Ability to effectively create 3D engineering models, assemblies, fixtures, and drawings (Solidworks preferred)
- Ability to create proof of principle, experimental designs and collect, interpret, and analyze data using statistical techniques (Minitab preferred)
- Strong technical writing skills (planning, protocol writing, execution, report writing)
- Demonstrate excellent understanding of medical device product development including risk management methodologies
- 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, focusing on design for manufacturing on manual and automated applications
- Resolve highly sensitive and complex issues within the department
- Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)
- 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 and execute on high-quality deliverables to meet defined goals
- Anticipates the need to shift priorities to provide the best possible response to cross functional teams
- Apply strong cognitive ability to collecting, processing, and disseminating information
- Strong ability to foster teamwork, collaboration, negotiation, coaching, and influencing others
- Make a positive impact on others in support of company goals and a healthy work environment
- Excellent time management skills
Physical Requirements - Must be able to remain in a stationary position for extended periods of time
- Must be able to access and navigate all areas of the facility, including clean rooms, and labs
- Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
- Ability to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time
- Position requires being physically present on the premises during regular company hours or as approved by management
RESPONSIBILITIES - Lead process design and optimization through design of experiments and engineering studies
- Lead 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
- Equipment Qualification (installation, operational and process qualifications (IQ/OQ/PQ) to meet regulatory requirements
- Create test protocols to challenge equipment performance against intended specifications. Execute protocols and write validation reports
- Design and execute Measurement System Analysis (MSA) such as Gage R&R in addition to calibration routines and specifications to verify accuracy and precision, repeatability and reproducibility
- Process and Test Method Validation to meet regulatory requirements. Includes writing protocols, execution of the protocol, and writing the validation report
- 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 and R&D
- 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
- Project Manager for manufacturing engineering initiatives, identify scope, schedule, and resources to complete and manage activities to support new processes or equipment
- Resolve internal and external (customer or supplier) issues related to manufacturability and performance of product
- Identify preventative maintenance requirements
- Train personnel on how to maintain and repair equipment
- Delegate tasks to other engineers, technicians, and co-ops within the department
- Lead 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 within and outside of the manufacturing department
- 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
- Identify key project constraints such as scope, schedule, budget, resources and risks and will clearly communicate roles, expectations and accountabilities to team members on a regular basis
- Define strategic outcomes to meet corporate and pharma partner goals
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