Job Type Full-timeDescriptionPURPOSE OF POSITIONThe Manufacturing Engineer is responsible for sustaining production and implementation of new and improved manufacturing processes for manufacturing product lines, as well as performing other duties as assigned by their supervisor. This individual will provide daily support of products, processes, materials/supplier management, and equipment for new and sustaining products.ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
- Manage medium complexity projects, including communication with internal customers, involving designs or processes.
- Provide technical support to the manufacturing product lines.
- Identify and implement process improvements to increase efficiency and reduce costs.
- Design tools & fixtures (electrical/pneumatics/mechanical) to improve production efficiency.
- Ability to use Solidworks or similar software for product and fixture drawings.
- Develop and maintain manufacturing processes, work instructions, forms, BOMs, routers, FMEAs, DMRs, and other documents as required.
- Collaborate with cross-functional teams to ensure products are manufactured to specifications.
- Participate in product design and development activities, including Design for Manufacturability (DFM) reviews.
- Support process validation activities, including writing and/or performing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Develop and maintain equipment and tooling requirements, including purchasing and maintenance schedules.
- Support new product introductions and product transfers to ensure a smooth transition into manufacturing.
- Ensure compliance with all relevant regulatory requirements and industry standards.
- Evaluate quality control processes and make recommendations for improvements.
- Analyze production processes, schedules, methods, and other data. Provide management with reports containing the data and statistics to enable management to better understand future requirements needed for the manufacturing process.
- Review and calculate labor, material, and other production costs along with reviewing schedules and future production requirements to assist management in decision making.
- Analyze and plan workflow, equipment placement, and space requirements to improve manufacturing efficiency.
- Utilize Six Sigma tools to improve efficiency in manufacturing setting.
- Perform and/or coordinate equipment maintenance and repair services to ensure production equipment is operating optimally.
RequirementsKEY COMPETENCIES
- Experience with computer programming (e.g., Python, MATLAB, etc.).
- Experience with industrial automation, specifically that which uses PLCs and robotics.
- Formal Root Cause Analysis (RCA) training.
- Experience with testing of electro-mechanical medical devices.
- Experienced in supply chain, supplier process development/optimization.
- Experience providing product sustaining activities including technical support of products as they move into the latter or mature stages of the product lifecycle.
- Experience with obsolescence management, software and/or hardware release support, regulatory updates, etc.
- Experience with contract manufacturing of medical device products and/or components.
- Knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements.
- Experience with electronic and/or mechanical assembly.
- Experience with automated assembly equipment.
- Experience with sustaining and process engineering.
- Lean Six Sigma certification.
- Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer experience, product/process failure mode and effects analysis (FMEA), and problem-solving methodologies.
EDUCATION & EXPERIENCE REQUIREMENTS
- Bachelor's degree in engineering or a related field.
- 3+ years of experience in a medical device manufacturing environment.
- Knowledge of manufacturing processes and equipment.
- Experience with process validation activities and regulatory requirements (e.g., FDA, ISO).
- Excellent problem-solving skills and ability to work independently.
- Strong communication and interpersonal skills.
- Ability to manage multiple projects and priorities simultaneously.
- CAD software experience (e.g., SolidWorks)
- Experience with creation and implementation of new manufacturing processes and documentation.
PHYSICAL AND COGNITIVE DEMANDSThe physical demands described here are representative of those that must be met by an employee tosuccessfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- This position is primarily based out of the company headquarters in Durham, NC.
While performing the duties of this job, the employee is regularly required to:
- Complete all company required training that is specified for the role, as defined by our compliance and training processes and protocols, which may be job specific or corporate/compliance related.
- Listen and communicate using both verbal and written feedback. Must be able to exchange accurate information in these situations.
- Maintain a high level of consistent cognitive function.
- Perform consistent keyboarding/computer use in a typical office environment for extended periods of time, up to 8 hours per day.
- Frequently move about the office.
- Stoop, kneel or crouch when maneuvering in the office environment.
- Sit/stand for extended periods of time, up to 8 hours a day.
- Perform work in manufacturing and/or scientific laboratory environments for extended periods of time, up to 8 hours per day.
- This position requires to be physically present at the work site and is not a remote role.
- Lift up to 50lbs at times.
- Be fully vaccinated against Covid-19 or meet the requirements for a medical or religious exemption.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions and perform any other duties, as assigned by their manager.