The Product Engineer will be a key member of the Manufacturing team providing technical engineering expertise to the manufacturing, research and development teams, and work closely with manufacturing partners. This position requires professional judgment and independent initiative in determining work methods, time management and professional documentation to support the production and engineering of the company’s commercial devices regulated by ISO and the FDA. This position will work independently and in a team environment.
- Generate and execute sustaining engineering design changes, including design/specification work, design verification and validation, document approval, and implementation.
- Act as sustaining engineer for our external manufacturing partners and work independently to maintain the technical qualification of suppliers
- Work with suppliers to resolve complex technical issues that may require the development of new or improved techniques or procedures.
- Initiate and manage process excellence project to improve quality, yields and value received from supply chain
- Develops test plans, DOEs and validation IQ/OQ/PQ protocols and successful execution of each
- Lead or support troubleshooting activities, investigate the root cause to a successful conclusion and help resolve product complaints and CAPAs
- Identify, characterize, and document all key process variables included in design transfer
- Technical report writing, statistical analysis and data evaluation
- Ensure all products are manufactured according to Zoll’s design specifications and quality requirements.
- Assist with production planning, sourcing, supply chain logistics and inventory management.
- Support the company’s contract manufacturers in the development, maintenance and continuous improvement of manufacturing processes and equipment
- Evaluate components, subassemblies and full units for performance and work with component suppliers and contract manufacturers to adjust design/specifications to optimize manufacturability
- Participate in the document control process
- Assist cross-functional teams in maintaining risk assessment documentation including design and process FMEAs
- Develop and maintain assembly/test methods and equipment
- Operations sign off on new product development documents
- Participate and lead projects to decrease product cost and improve product quality
- Help resolve supplier quality issues
- Generates and maintains project timelines and provides updates and feedback to supervisor
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Management System and all other quality processes and procedures
- Other duties and responsibilities as assigned
- Bachelor’s degree in a relevant technical discipline (eg. Engineering, Science, etc.)
- 2 -5 years or more in manufacturing engineering experience in industry
- Strong Analytical / problem solving skills with a demonstrated ability acquire, use and critically evaluate complex information
- The ability to plan, priorities and make conclusions under pressure
- Ability to appreciate the need for economically viable solutions
- Detailed knowledge of FDA, GMP, ISO 13485:2003
- Strong computer competency in MS Office - Word, Excel, Outlook, Minitab or other statistical software
- Detail oriented, highly organized individual
- Excellent verbal, interpersonal and written communication skills
- Preferred experience with Computer Aided Design software (CAD – Pro E or Solid Works)
- Current passport (ability to travel)
- Valid driver’s license (ability to travel)