Engineer II - Manufacturing Engineer - Med Device

ENGINEER II -  Medical Device Product Development & Manufacturing Engineering (Vascular Access Devices)

Position Summary

The Engineer II role supports the design, development, validation, and sustaining engineering of vascular access devices and their associated manufacturing processes. Working within established procedures and under general supervision, the Engineer role II independently executes defined engineering projects — including test method development, process and equipment qualification, fixture design, and technical investigations — and documents the results in compliance with the Quality Management System and applicable regulatory requirements. The role escalates novel or ambiguous technical problems to senior engineering staff and contributes to cross-functional design and process review activities.

Essential Duties and Responsibilities

Design and Development Support

• * Provide project support including device and component testing, protocol authoring, documentation of test results, data analysis, and preparation of technical reports in accordance with design control procedures.
• * Contribute to Design History File (DHF) and Device Master Record (DMR) content for assigned projects.
• * Design, model, and fabricate test and manufacturing fixtures, including CAD modeling and additive manufacturing (3D printing) of prototypes.
• * Participate actively in design and process reviews.

• Test Method and Process Validation

• * Design and execute test method validations (TMV), measurement systems analysis (MSA) including Gage R&R studies, and designs of experiments (DOE); analyze and report results.
• * Support line validation and qualification activities including IQ, OQ, and PQ — authoring protocols and reports and executing testing.
• * Develop and document statistical rationale for sampling plans, sample sizes, acceptance criteria, and confidence/reliability targets.

• Risk Management and Quality Systems

• * Participate in risk management activities including PFMEA, DFMEA, and use-related FMEA (uFMEA), and contribute to the risk management file in accordance with ISO 14971.
• * Perform process mapping and support process characterization and improvement initiatives.
• * Author and assess engineering change orders (ECOs) and change control records, including impact and validation assessments.
• * Provide technical investigation support for nonconformances, CAPAs, and complaint investigations. Complaint reportability and regulatory decisions remain the responsibility of Quality Assurance and Regulatory Affairs.

• Manufacturing and Supplier Support

• * Interact with suppliers and vendors to facilitate new manufacturing processes or changes to existing processes, including technical support during process transfers.
• * Perform product and component inspections in compliance with company policies and procedures.
• * Support shipping and receiving of commercial product and components as required.

• Qualifications

  Required

• * Bachelor's degree in Mechanical, Biomedical, Manufacturing, or a related engineering discipline.
• * 2-5 years of engineering experience, preferably in medical device or another FDA-regulated manufacturing environment.
• * Working knowledge of design controls and validation principles (IQ/OQ/PQ, TMV, MSA).
• * Demonstrated ability to author clear technical protocols and reports suitable for a regulated document system.
• * Proficiency with 3D CAD software (e.g., SolidWorks) and standard office productivity tools.

• Preferred

• * Familiarity with medical device standards and guidance documents.
• * Experience with statistical software (e.g., Minitab, JMP) and applied statistical methods.
• * Experience with GD&T and inspection method development.
• * Experience with catheter, guidewire, or other vascular access device manufacturing processes.

• •* Experience working in an ISO Class 7/8 controlled environment.