Bachelor's Degree in a technical discipline (e.g., Engineering or Science) or equivalent education/experience
8+ years in process/equipment design for new product development and manufacturing
Proven leader of cross-functional teams and projects
Experience with medical device manufacturing: heat staking, ultrasonic and laser welding, robotics
Strong knowledge of Product DFMA (Design for Manufacturing and Assembly)
Responsibilities
Lead and mentor manufacturing engineering teams
Prioritize tasks to align with corporate strategies
Design and develop innovative manufacturing processes and equipment
Review and approve manufacturing process documentation
Qualify equipment according to regulatory standards (IQ/OQ/PQ)
Create and execute test protocols for equipment performance
Write and manage validation reports with comprehensive documentation
Benefits
Work in a collaborative and supportive corporate culture
Opportunity for professional growth in a high-tech industry
Engage in diverse, cross-functional projects
Participate in a dynamic work environment
Enhanced skills through training and development opportunities
Full Job Description
Location: Onsite
Status Type: Full Time
QUALIFICATIONS
Required:
Bachelor's Degree in a technical discipline (e.g., Engineering or Science) and/or education/experience equivalent
A minimum of 8 years of experience in process/equipment design and development to support new product development and manufacturing
Experience leading cross functional teams, projects, and/or direct reports
Experience with medical device manufacturing process technologies: heat staking, ultrasonic and laser welding, press assembly, robotics, leak and flow testing, functional testing
Experience with Product DFMA (Design for Manufacturing and Assembly)
Preferred:
Experience in a high-volume manufacturing environment preferred, i.e., production 1M+annual, cycle time < 1 second
Experience with customequipment procurement and qualification such as via the GAMP process
Skills & Competencies:
Leadership - ability to create a vision and motivate employees to strive to create that vision
Attention to detail
Strong influencing and negotiating skills
Excellent verbal communication and technical writing skills
Proficient with spreadsheet and statistical analysis software packages (Excel and Minitab preferred)
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
Experience with the validation life cycle (planning, protocol writing, execution, report writing)
Understanding and application of Good Automated Manufacturing Practice (GAMP)
Proficient with the MS Office Suite (Word, PowerPoint, Excel, etc.)
Physical Requirements:
Must be able to remain in a stationary position for extended periods of time (desk work).
Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
RESPONSIBILITIES:
Lead direct reports such as manufacturing engineers
Delegate and prioritize tasks to align with corporate strategies
Lead the design and development of manufacturing processes and equipment
Review and approve manufacturing process documentation
Creation of manufacturing process development documentation
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
Process validation to meet regulatory requirements
Write protocols, execution of the protocol, and write the validation report
Standard operating procedures create, revise, and implement including necessary change order, training, and verification activities
Test methods, write and execute test method validations such as Gauge R&R studies
Project management, prepare overall project proposals including cost estimates and schedule for designated projects
Assign priority and schedule tasks to provide timely solutions to achieve results
