Principal Engineer - Disposables R&D, Sustaining -Hybrid

DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at to learn more and view our open positions.

• This section focuses on the main purpose of the job in one to four sentences.
• Technical lead for DHF structure within sustaining engineering for disposable medical devices.

• 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.
• Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets.
• Manage change controls from initiation through execution.
• Lead the creation and maintenance of design history files.
• Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
• Schedule, budget, and lead engineering projects with minimal guidance.
• Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.

• 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.
• Experience in managing medical device product support activities and change controls.
• Experience managing supplier relations & records management.
• Experience managing design output strategies across different product families.
• Experience managing design transfers from R&D to manufacturing.
• Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
• Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
• 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.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.