Summary of the roleAs a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.
Job Summary:The Senior Manufacturing Engineer is responsible for providing support to manufacturing and technical operations while maintaining a strong focus on continuous improvement and productivity optimization. This role will lead production optimization, develop advanced manufacturing processes, and introduce new products (NPI) to ensure efficiency, quality, and cost-effectiveness. This role will oversee planning, preparing and executing projects related to the machinery used for the manufacture and assembly of medical and inflation products.
Required Knowledge, Skills and Abilities - Process Improvement: Drive Lean, Kaizen, and automation initiatives to boost capacity, improve efficiency and reduce downtime.
- New Product Introduction (NPI): Bridge R&D and production, leading product transfer, factory readiness, and design-for-manufacturability (DFM) reviews.
- Technical Leadership: Draft and execute validations (IQ/SQ/OQ/PQ) for manufacturing processes, tools, and equipment. Draft machine specifications for CapEx projects. Manage CapEx projects from start to finish. Write Engineering Change Orders. Draft Standard Operating Procedures.
- Troubleshooting & Quality: Troubleshoot and debug special cause problems on assembly equipment. Perform root cause analysis, corrective actions, and maintain FDA/ISO compliance. Provide technical support for CAPA investigations.
- Mentorship: Provide guidance to junior engineers and technicians.
- Vendor Management: Interface with customers and suppliers effectively.
- General Computer Skills: MS Word, Excel, Outlook, PowerPoint.
- Design: Tooling and fixture design experience.
- General knowledge of welding, machining (mill, lathe, EDM, and CNC).
Behavioral Attributes- Effectively manage multiple projects concurrently.
- Communicate clearly and professionally with internal and external suppliers and customers.
- Work effectively as part of a team to achieve successful outcomes.
- Pay close attention to detail in all aspects of the job.
- Make decisions using available resources, sound judgment and reliable data.
- Maintain confidentiality and discretion.
- Identify and resolve problems in a timely manner.
- Effectively teach, coach, and counsel associates by effectively communicating and providing follow-up.
- Open to other's ideas and exhibits a willingness to try new things.
- Prioritize and plan work activities efficiently.
- Adapt to changes in the work environment. Manage competing demands and deal with frequent change, delays, or unexpected events.
- Follow instructions, responds to direction, and solicits feedback to improve.
- Act in such a way to instill trust from management, other associates, as well as customers.
Education and Experience- Education: Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Electrical Engineering, Industrial or equivalent
- 8+ years of experience, preferably in a medical device or other FDA regulated industries
- Proficient in CAD software (e.g., AutoCAD, SolidWorks) and ERP systems.
Preferred Knowledge, Skills and Abilities- Experience with Fanuc and Epson robots.
- Knowledge of various automation systems.
- Knowledge of vision systems (Cognex and Keyence), ultrasonic welding and leak testing.
- Experience in an ISO and/or FDA regulated medical device manufacturing environment, especially with plastic injection molded components.
- Electrical troubleshooting skills, use of volt/current meters with low voltage DC and 120/240/480 VAC.
- Knowledge of vibratory feeding systems
- Understanding of PLC Ladder Logic for PLC debugging and programming. Preferably with Allen Bradley PLCs.
- Able to use a computer to connect to PLCs HMIs and other programmable devices for monitoring and troubleshooting. Knowledge of Ethernet/IP protocol.
- Experience interfacing with suppliers to support process development and cost reduction for new products.
- Understanding statistics and proficiency using MiniTab. Six Sigma (green belt or black belt) experience.
- Knowledge of injection molding.
- Familiar with standard concepts, practices, and procedures within an ISO9001 facility.
#LI-NS1
Interested?If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.
