Position Summary: This position is key to supporting the manufacturing of Class III implantable Neuromodulation system components for pain management. The Manufacturing Engineer partners with Operations, R&D, Quality, Regulatory, and Contract Manufacturers (CMs) to develop, validate, and scale robust, efficient manufacturing processes. The role is primarily focused on manufacturing/process engineering for mechanical components and assemblies, with electrical components and test experience considered an asset.
Essential Functions:- Lead and support the manufacturing of Neuromodulation system components and assemblies, focusing on process development, optimization, and troubleshooting.
- Own projects related to second sourcing, cost reductions, manufacturing transfers, tooling, fixturing, and equipment validation.
- Drive and implement process improvements to increase yield, productivity, and quality, and reduce cost and manufacturing risk.
- Participate in manufacturing transfer and DFM activities with device assembly manufacturing sites and suppliers.
- Develop and sustain comprehensive manufacturing and product documentation (BOMs, product/component specs, MPIs, process validations, pFMEAs, CHOs/ECOs).
- Collaborate and communicate effectively with contract manufacturers and suppliers, leading process validation and qualification activities (IQ/OQ/PQ/PPQ).
- Act as a key resource for addressing issues encountered during manufacturing, driving root cause analysis and resolution.
- Ensure compliance with Quality System regulations and actively enforce their objectives.
- Travel up to 10%, including domestic and international visits to suppliers or manufacturing sites.
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
- Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.
- Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- B.S. Mechanical Engineering, or related technical field.
- 5+ years of experience in manufacturing engineering, preferably in the medical device industry.
- Proven hands-on experience with manufacturing process development, assembly, tooling/fixturing, and process validation.
- Experience working with contract manufacturers and suppliers.
- Working knowledge/ experience with FDA submission process, ISO 13485, and QSR requirements.
- Strong mechanical, manufacturing, and process engineering fundamentals.
- Ability to lead projects and utilize structured project management tools.
- Excellent analytical, problem-solving, and technical writing skills.
- Strong interpersonal and cross-functional collaboration skills.
- Experience with injection molding, machining, resistance welding, laser welding a plus.
- Electro-mechanical design/manufacturing and analysis skills a plus.
- Experience with mechanical tolerance stack-up analysis.
- Experience with Solidworks, statistical analysis tools.
- Experience with PCBA processes, component obsolescence, electronics manufacturing a plus.
Physical Demands:The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
