About OPT Industries
The global ecosystem of manufacturing is experiencing fundamental change. Additive manufacturing is a key technology to shorten supply chains and create superior products in medical, cosmetic, textile, and packaging industries, as well as and many other domains.
OPT Industries (http://optindustries.com) is a rapidly growing, venture-backed MIT spinoff company that focuses on building the next generation of additive manufacturing technology. We design and manufacture custom textile materials and products - everything from medical devices to luxury fashion. As we continue to grow and expand our operation, we are looking for manufacturing assistants to join our production team.
The Senior Design Assurance Engineer will provide Design Assurance engineering support projects within product families across the full product lifecycle. This role will plan and execute design control activities for non-routine problems requiring judgment in the independent evaluation, selection and adaptation of standard engineering techniques, procedures and criteria, while actively engage and participate in development of new approaches to the design of new or modifications to products under development and distributed commercially. This position will manage workload ensuring work activities and results are consistent with program requirements and the state of the product, and provide direction to cross functional teams as it relates to Risk Management activities associate with ISO 14971 and internal procedures.
· Generate and review quality plans, agreements, product specifications, uFMEA & dFMEA, component qualifications, and design verification / validations.
· Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
· Launch and stabilize new product launches through concept, design, development, and steady-state processes.
· Drives the development of product requirements, verification strategies, and validation strategies.
· Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards.
· Provide support and expertise in developing and executing a reliability strategy during new product development.
· Review and approve R&D SOPs, quality SOPs, FMEAs, product verification & validations, and other applicable documents through document control system for conformance to FDA regulations along with business SOPs.
· Design and develop prototype and design test methods to help fully understand customer requirements to enable defined design specification requirements.
· Works with R&D to assess and address purchased product issues.
· Design and conduct experiments for design for manufacturability, design optimization, quality improvement, and cost reductions.
· Facilitate, participate in and/or lead formal risk assessments.
· Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, and analysis of data.
· Support the Risk Management Process per ISO 14971 and construction / maintenance of the Risk Management File.
· Identifies and advises leadership on potential improvements to quality systems and processes in the company.
· Champions 100% compliance to ISO regulations, company policies and SOP’s.
· Work closely with functional teams including Chemical Development, Product Design, Commercial, Software Design Development, Quality Engineering, and other functions to provide guidance and expertise on Interpretation of cGMP, regulatory requirements, directives, and guidelines from Quality Management System and from established regulatory agencies that OPT Industries is doing business within those regions.
· Review and perform Quality Assurance approval of complex change controls, responses, investigations, and CAPAs. Apply and interpret current regulations, requirements of ISO standards, and local procedures, to ensure records are clearly and appropriately justified.
· Support continuous improvement of quality and research & development systems using LEAN tools and implementation of actions arising from continuous improvement events.
· Provide statistical support and expertise along with analytical problem solving for design development.
· Carry out duties in compliance with all state and federal regulations and guidelines, including FDA, EPA, and OSHA.
· Adhere to the Safety Code of Conduct & EHS policies and attend all required EHS training.
· Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
· 5+ years of design assurance or quality engineering experience supporting new product launches within a regulated industry
· Bachelor’s Degree in Engineering, Sciences, or related discipline, Masters Degree preferred
· Engineering experience and demonstrated use of Quality tools/methodologies.
· Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
· Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
· Advanced computer skills, including statistical/data analysis, presentation, and report writing skills.
· Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean).
· ASQ CQE or other certifications preferred.
· Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
· Ability to travel approximately 5 - 10%, including internationally.
· Experience in change control
· Knowledge of regulatory agency enforcement trends
· Experience implementing and/or sustaining Quality Management System along with document control management.
OPT Industries provides the following benefits to all full-time employees:
Medical, Dental, Vision, STD, LTD, Life and AD&D Insurance, Tax Free Commuter Benefits, 401k, and more.
OPT Industries is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.