US_East | Manufacturing & Process Engineer_L2

Essential Duties and Responsibilities

• Supports design quality activities throughout new product development, including design reviews, requirements review, risk management, verification and validation planning, and design transfer readiness.
• Supports design transfer activities by ensuring product and process requirements are translated into manufacturing, inspection, supplier, validation, and release deliverables.
• Lead and participate in Design Failure Modes and Effects Analysis (DFMEA) and risk assessments.
• Participate in DFMEA, PFMEA, process flow, control plan, and risk assessment activities to ensure design and manufacturing risks are identified, mitigated, and documented.
• Review protocols and participate in V&V planning to ensure alignment with product requirements.
• Review verification, validation, inspection, equipment qualification, and process validation protocols to ensure alignment with product requirements, risk controls, and design transfer needs.
• Support execution and documentation of equipment qualification and process validation activities, including IQ/OQ/PQ, validation reports, and related production readiness evidence.
• Support Design Control activities by ensuring compliance with FDA and international regulations.
• Support supplier/process readiness activities, including review of supplier documentation, inspection results, capability studies, MSA/Gage R&R, and approval packages.
• Develop and execute supplier qualification processes, including supplier contracts and PPAPs.
• Develop various inspection techniques and procedures to ensure product integrity to design specifications.
• Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures and operator self-inspection procedures.
• Works with other Quality Engineers and the Metrology Lab personnel on the development of all product gaging.
• Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems.
• Assists each of these groups with capability studies and the application of statistical quality control.
• Interfaces with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies.
• Recommends process monitoring devices where applicable.
• Aids in complaint investigation and documentation interfaces with Regulatory Affairs to support UL, IEC, and FDA submissions.
• Participates in internal audits conducted by internal employees and regulatory agencies.
• Manages and drives timely resolution of nonconformances (Company) and corrective & preventive actions (CAPAs).

Qualification Requirements

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• EDUCATION and/or EXPERIENCE: Bachelor’s degree in Engineering, Quality, or a related field (Master’s preferred). 3+ years of experience in medical device quality engineering or a related field.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
• Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
• Proficiency in statistical analysis tools (MinitabJD) and problem-solving methodologies (8D, DMAIC).
• Certified Quality Engineer (CQE) or Six Sigma certification is a plus.

Key Competencies

• (Leadership skills/behaviors) Building Strategic Working Relationships-Developing and using collaborative relationships to facilitate the accomplishment of work goals.
• (Quality Orientation)-Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time.
• (Decision Making)-Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
• (Performance/Work Standards)-Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks.