Summary of Primary Responsibilities:
This position is primarily responsible for supporting new product development with experience in design control and risk management. Supports R&D in the maintenance of the Design History Files (DHF). Works closely with Operations, Regulatory, Research & Development and the CMO to ensure Design Controls are performed appropriately and a high level of compliance is maintained.
This position will also support post market product sustaining activities such as design changes, customer complaint investigations, and CAPAs.
The individual in this role will also drive continuous improvement in the quality management system to ensure compliance with regulatory requirements during product development.
Supports internal and external regulatory audits.
- 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.
- 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.
- Performs QA review of new and revised procedures, technical protocols, validations and reports as assigned.
- 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.
- Conducts gap analyses of in-house practices versus relevant regulations, standards and industry practices; develops plans and implements corrective actions to ensure continued compliance.
- 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 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:
- Bachelor’s Degree in science, engineering or related discipline is preferred, or relevant experience.
- Requires a minimum of 3 years related experience and demonstrated working knowledge of scientific principles in medical device product development and design controls
- 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 Part 820, ISO 13485, EU MDR, and MDDs
- Proficiency in Microsoft Office Suite (i.e., Word, Excel, PowerPoint, Teams)
- Experience with statistics and statistical analytics tools (e.g., Minitab) preferred
- Working knowledge of Six Sigma a plus
- Strong writing and verbal presentation skills
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.