PURPOSE AND SCOPE

Participate in the New Product Development (NPI) and design changes, Design History File (DHF) and Device Master Record (DMR) reviews meetings and fully understand the design control process and Quality Engineering. Utilize technical training and compliance experience to ensure that company design control projects comply with internal design control procedures in accordance with FDA and ISO requirements.

PRINCIPAL DUTIES AND RESPONSIBILITIES

· A seasoned, experienced professional with a full understanding of design control process; resolves a wide range of issues in creative ways.

· Responsible for assuring projects meet customer expectations, and regulatory requirements.

· Act as a subject matter expert on design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV).

· Successfully address complex engineering issues where analysis of situations or data requires an in-depth evaluation of variable factors.

· Provide guidance to engineering staff and other personnel, and ensure that design control requirements are being met in an effective manner in order to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review.

· Provides input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF files for accuracy and completeness and provide guidance on FDA compliance and procedures.

· Review and approve design control related Change Notices (CNs) within the documentation system as applicable.

· Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards.

· Represent the design quality functions for the review and approval of designated design outputs.

· Assist in the development and maintenance of company procedures for design control, change managements, risk management, process validation and related areas of the quality management system.

· Work independently on high visibility new product development projects; including projects involving multiple technologies and design sites.

· Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.

· Assist with various projects as assigned by a direct supervisor.

· Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS

· The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION

· Bachelor’s Degree in related engineering or scientific discipline required; Advanced Degree desirable

EXPERIENCE AND REQUIRED SKILLS

· 5 – 8 years’ related experience;

· Master’s degree with >3 years’ related experience;

· PhD without experience; or equivalent directly related work experience.

· Working knowledge of Software development lifecycle

· Working knowledge of IEC 62304

· Risk management (ISO 14971)

· Sofware as a Service/SaMD product development

· IEC 82304 - Health Software

· Understanding of how Agile Software Development practices work with the FDA/EU Quality

· Creative problem solving

· Windchill and Polarion software experience is a plus

ADDENDUM

Product Security Expert

This position is also a cybersecurity and data privacy Subject Matter Expert for global PD products.

Duties and Responsibilities

· Assessing the acceptability of cybersecurity residual risks

· Definition of required countermeasures and preparation of the risk/benefit assessments

· Involvement in the planning of the product roadmap for the implementation of appropriate cybersecurity measures

· Evaluation of events (post-market surveillance) within the scope of complaints/incidents and vulnerability management coordination of product related cybersecurity activities

· Involvement in the definition of policies, SOPs and guidelines for cybersecurity and data privacy

Experience

· 2+ years of relevant experience in medical device cybersecurity and data privacy