Principal Engineer

• This section focuses on the main purpose of the job in one to four sentences.
• Leads design and development of product changes within sustaining engineering for disposable medical devices.

Essential Duties and Responsibilities:

• This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
• Schedule, budget, and lead engineering projects with minimal guidance.
• Serve as the technical expert for design change programs. (e.g. new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
• Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).
• Lead the creation and maintenance of design history files.
• Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
• Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
• May supervise engineers and/or technicians.
• May contribute to Client's intellectual property through invention disclosures and patent applications.
• The Principal Engineer will act as a technical lead on the disposable project, supporting the day-to-day execution and oversight of engineering activities related to medical device product support.
• Strong understanding of product assembly processes, change control, and medical device manufacturing.
• Proven experience in design transfer from R&D to manufacturing
• Strong understanding of product assembly and manufacturing operations
• Familiarity with Design History Files (DHF) and product specifications
• Experience in remediation projects is highly desirable
• MDR (Medical Device Regulation) experience is a plus
• Experience working with or supporting manufacturing plants

Qualifications: 

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• Advanced knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
• Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
• Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks).
• Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
• Creative Problem Solver – identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks.
• Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.
• Ability to train and coach others from technical expertise.
• Self-directed, resourceful, and able to manage multiple priorities.
• Strong interpersonal, communication, collaboration and influencing skills.
• Ability to read, write and comprehend English.

Experience and/or Background

• BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
• 5 - 8 years of related experience in Class II or Class III disposables medical product development