Engineering Specialist - S4

Engineering Specialist - S4

Responsible for supporting and assisting software/mechanical/ or electrical engineering activities. Often involves specialized equipment in a laboratory or bench environment.

Responsibilities:

• Supports tools and/or software by creating and maintaining tools, involving others as appropriate to solve issues.
• Maintains detailed documentation through all phases of development, testing and analysis.
• Reviews or develops processing or manufacturing instructions.
• Continuously improves process and work methodologies by interfacing with peers, engineers, and analyzing activities to improve workflow and work processes.
• Documents test results and test reports by writing documents, reports, memos, change requests. Methods used are determined by approved procedures and standards.
• Works from schematics, engineering drawings, and written or verbal instructions.
• Responsible for the final Process Monitor Release for products prior to distribution.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, investigating and resolving quality issues.
• Develops and implements process improvements by researching and validating changes for processes, equipment and test methods.
• Supports process development during new product introduction by defining traceability and inspection requirements, developing statistical process control criteria, developing manufacturing instructions, and creating training sheets and certifications. May also train operators on processes and engineering changes, and perform operator certification on-the-job training and testing.
• Provides input to engineering, qualification, and validation studies and reports by collecting, compiling, measuring, organizing and recording data, and by writing procedures.

Requirements:

• Associate degree and 6+ years of experience or an equivalent combination of education and work experience.
• Familiarity with CAD tools (e.g., SolidWorks) for simple fixture design or design review is a plus.
• Ability to design and implement new test systems/methods or modify existing systems/methods to meet evolving R&D needs.
• Strong capability to perform root-cause analysis, including failure mode identification, data interpretation, and documentation of conclusions.
• Hands-on skills executing device testing and troubleshooting issues with minimal supervision.
• Working knowledge of implantable medical devices and experience in a regulated medical device environment.
• Proficiency in documentation and technical writing (generates and executes test protocols, reports).
• Experience in data analysis skills, including summarizing results and identifying trends.
• Ability to manage multiple requests and work effectively with a team of R&D engineers.
• Strong organizational skills and attention to detail.
• Fully bilingual.
• No restrictions to travel as needed.

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.