Summary of Primary Responsibilities:
This position is primarily responsible for supporting new product development with Quality expertise in design control, risk management, and human factors/usability engineering of medical devices. The individual in this role will also drive continuous improvement in the quality management system to ensure compliance with regulatory requirements for product development. This individual will collaborate and partner with Research & Development, Regulatory, Clinical, Marketing, and Manufacturing to achieve optimal results.
- Participates in the development of customer requirements (user needs) and design inputs; works with cross-functional team to ensure that customer requirements can be validated and design requirements can be verified
- Creates, approves, and maintains Design History File (DHF) deliverables as part of the design control process for new product development
- Facilitates the Risk Management Process in accordance with the latest version of ISO 14971; ensures integration of risk management outputs with design, process, and regulatory requirements
- Develops, reviews, and approves validation and verification protocols/reports to ensure quality attributes and analysis are being conducted as part of new product development
- Supports post market product sustaining activities, such as design changes, customer complaint investigations, and CAPAs
- Conducts gap analyses for new/updated regulations and standards; develops plans and implements actions to ensure continued compliance for product design and the quality management system
- Support development and implementation of company-wide quality initiatives
- Supports internal and external regulatory audits
- Performs other related duties as assigned
Requires thorough knowledge of FDA, ISO, and other regulatory guidelines related to the development and manufacturing of medical devices. Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting method and techniques for obtaining solutions.
No direct reports. Has responsibility to oversee diverse teams in the implementation of projects.
Experience, Knowledge and Skills Required:
- Requires a Bachelor’s Degree in science, engineering or related discipline; Master’s Degree preferred
- Requires a minimum of 5 years related experience and demonstrated working knowledge of scientific principles in medical device product development and design controls
- Experience leading projects across functions and sites
- Working knowledge and demonstrated application of ISO 14971 Risk Management for Medical Devices
- Demonstrated experience working with US and international regulations/standards including 21 CFR, 820, 210, 211, ISO 13485, EU MDR, and MDDs
- Proficiency in Microsoft Office Suite (i.e., Word, Excel, PowerPoint, Teams)
- Experience with statistics and statical analytics tools (e.g., Minitab) preferred
- Strong written and verbal communication skills
- Experience in delivering presentations on complex quality-related issues and topics
- Working knowledge of Six Sigma preferred
- Ability to travel up to 10-15%
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.