What are the responsibilities and job description for the Manufacturing Engineer position at Extremity Care?
Job Description
Job Description
Salary :
The Manufacturing Engineer is responsible for bridging the gap between current manufacturing operations and future product development. This role also provides technical assistance and engineering support to the operations group while collaborating with Product Development Engineers to ensure design for manufacturability (DFM). The position focuses on improving existing processes, developing new manufacturing concepts, integrating advanced solutions, and ensuring efficient, cost-effective, and quality-driven operations.
Responsibilities
Collaborate with New Product Development (NPD) teams to evaluate and enhance product design for manufacturability and scalability
Collaborate with NPD team to ensure effective integration of design control processes, including risk management, verification, validation, and compliance with regulatory standards throughout the product development lifecycle
Assist in creating and maintaining design history files (DHF) and provide input to ensure products meet quality and safety requirements
Define process requirements for new product launches, including equipment selection, process monitoring, and data collection
Create and execute validation and qualification protocols (IQ / OQ / PQ) for new products, equipment, tooling, and processes
Improve existing manufacturing processes and develop new cost-effective concepts
Lead initiatives such as scrap reduction, lean manufacturing projects, and value improvement activities
Evaluate and optimize production layouts and process flows to ensure efficient space utilization and maximize production output
Provide engineering support for various technical production areas
Conduct root cause analysis, implement corrective actions, and resolve material, tooling, and equipment issues
Develop technical solutions in partnership with equipment operations group and support the management of relationships with custom tooling / machine suppliers
Provide technical leadership and mentorship to third-party vendors and cross-functional teams
Assist in training production operators and mentor process technicians on newly developed or improved processes
Generate, update, and implement process documentation, work instructions, and troubleshooting guides
Utilize project management tools to establish timelines, manage action items, and meet milestones
Provide ongoing status reports and periodic progress reviews to management
Identify opportunities for improvement in existing production areas through best practices and potential automation
Execute and document validation activities, including FMEAs, capability studies, control plans, and process verification reports
Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP / CGTP, other relevant regulations / standards, and internal organizational policies and standard operating procedures
File and maintain records in accordance with standard operating procedures
Travel domestically and internationally up to 10% to attend offsite meetings, conferences, and support business initiatives
Work overtime during weekdays and on the weekend as needed to support business / operational needs
Perform other duties as assigned
Skills
Strong knowledge of regulatory standards, including FDA, AATB, and ISO requirements
R&D, new product development, and / or new process design skills, including design control, and knowledge
Mechanical and / or process design, automation, and process validation skills
Root cause analysis and lean manufacturing methodologies knowledge
Six Sigma Green or Black Belt certification preferred
Proficiency in AutoCAD and SolidWorks preferred
Excellent project management, problem solving, and organizational skills
Strong communication skills with the ability to collaborate across teams and departments
Excellent attention to detail and organizational skills
Ability to secure and maintain a favorable background investigation and clearance
Qualifications / Requirements
Bachelor of Science in an Engineering discipline (Mechanical, Biomedical Chemical preferred) from an accredited college or university required
Minimum of 5 years of experience in a manufacturing environment; FDA-regulated environment such as medical device, tissue, laboratory, etc is highly preferred
Experience in cleanrooms is highly preferred
Clearance of favorable background investigation required
