To plan and organize production schedules, assess project and resource requirements, estimate, negotiate, and agree on budgets and timescales with clients and managers
Develop, design, and improve processes and equipment for the manufacture of the Company’s medical devices that will meet established specifications and will conform to established cost limits. Work closely with the engineering team and contract manufacturing to effectively bring new products from concept to production. Direct on-going operations.
- Managing one or more manufacturing processes
- Assisting with planning and directing the layout of equipment
- Ensuring production follows appropriate workflow and assembly methods
- Hiring, scheduling, and training production staff
- Ensuring Manufacturing performance and Quality goals are met
- Apply engineering skills, in a collaborative team, to perform sustaining engineering tasks for released products.
- Understand and interpret schematics, component data sheets, and mechanical engineering drawings.
- Prepare and review documentation to support design history files (DHFs). Prepare production assembly instructions, and production testing procedures in accordance with cGMP standards.
- Maintain and improve existing product manufacturing processes. Anticipate Manufacturing’s need for new products and fixtures.
- Lead and provide guidance to technicians in the assembly, troubleshooting, testing, and repair activities of our products.
- Provide instruction and support to Manufacturing and QA on manufacturing techniques, procedures, and QC inspections.
- Survey and identify replacement components for reasons of obsolescence or cost reduction. Identify and contact vendors. Compare technical specifications. Compile and prepare required documentation.
- Conduct failure mode investigations (FMEA), and risk analysis of medical devices according to FDA QSR and international requirements.
- Travel to contract manufacturer and suppliers as needed to support product manufacturing. Participate as technical representative in vendor audits.
- Assure the timely manufacturing, packaging, and delivery of new products
- Identify, source, and implement improvements in manufacturing procedures
- Work with quality team to drive component issues upstream to suppliers. Use continuous improvement process in yield and quality/reliability programs
- Coordinate relationships with vendors and contractors.
- Support and conduct validation studies, technology transfer activities, process characterization studies, and gauge R&R studies within the Manufacturing Process. Provide guidance on the equipment/process validation requirements and design control activities for new product development projects.
- Lead cross functional group in conducting analysis of NCMR’s, with the purpose of evaluating the underlying issues and offering long-term solutions. This includes completion of required CAPA processes. Document and implement system improvements.
- Responsible for on-going process improvement: take initiative to define, plan, and execute improvement projects, achieve objectives in increasing yields, reducing cycle time, reducing overall cost, and improving product quality and reliability.
- Support manufacturing transfers to alternate suppliers.
- Bachelor’s Degree in Engineering preferred
Knowledge and Training
- Minimum 5 to 7 years of experience developing and manufacturing medical electronic devices. Experience manufacturing devices according to FDA and ISO 13485 requirements. Some knowledge of IEC 60601-x or equivalent specifications, strongly desired.
- At least 10 years of related work experience in a manufacturing environment, preferably in the medical device industry, and at least 5 years of relevant management experience.
- Demonstrated strong technical and analytical/problem solving skills
- Experience with engineering change orders, documentation needs, protocol and report writing. Familiarity with FMEA, DOE and QSR design control
- Ability to assess the feasibility of design modifications to existing designs
- Experienced in troubleshooting and recommending corrective or preventive actions to improve product reliability
- Experienced in interfacing with functional groups outside of engineering
- Good communication skills, verbal and written
- Knowledge of Supplier Quality Systems processes.
- Ability to assess the feasibility of process modifications to improve manufacturing quality and throughput.
- Strong interpersonal and collaborative skills. Works well as a supportive team member.
- Experience using SolidWorks mechanical CAD tool is desirable.