- Works within an integrated team to provide medical device design and product development subject matter expertise to create and advance products from concept to commercialization
- Knowledgeable, Hands On experience, and a thorough understanding of all aspects of the design, testing, fabrication and assembly of medical devices.
- Take ownership for guiding new products through the medical device Design Control process, with a thorough working knowledge of the requirements of 21 CFR 820.30 and ISO 13485.
- Assist and lend expertise in engineering problem solving activities related to existing products for the Device Business Unit.
- Analyzes, designs, develops solutions to engineering challenges associated with complex mechanical and fluidic assemblies, including those characteristic of combination drug/device products.
- Lead, develop test plans and execute Human Factors and Usability Engineering activities (including formative and summative testing) in accordance with requirements in AAMI/ANSI HE75, IEC 62366 and other applicable standards
- Recommends material specifications/standards for use in new products including resins, metals, packaging etc.
- In collaboration with manufacturing teammates, develops fabrication and assembly processes for new products and ensures Design for Manufacturability.
- Leads and potentially supervises other engineers and technical staff and ensures their development and training through mentoring and leadership-by-example.
- Deliver and ensure execution to plans and schedules to Project Management that fully describe the engineering tasks and resources required to design, transfer and launch new products.
- A comprehensive working knowledge of the use of statistical tools and techniques in the development of engineering designs.
- Responsible for the developing plans and budgets for equipment and materials to needed to support the Device Business Unit R&D activities, including overseeing the purchase and maintenance of laboratory and test equipment in accordance with Good Laboratory Practices and Emergent safety requirements.
- Will have responsibility to develop and deliver engineering documents, drive and lead engineering Design Reviews and oversee and execute design verification and validation.
- Apply a comprehensive working knowledge of the application of risk management tools in accordance with ISO 14971.
- Develop tolerance stack-up analyses and be able to predict proper fit to ensure reliability and performance; create and review engineering drawings using Geometric Dimensioning and Tolerancing (GD&T) and with proper application to yield the desired fits between joining parts.
- Assist investigation of device failures to determine root cause and corrective action.
- Responsible for development and execution of business unit long term strategic innovation strategies to populate the commercial product pipeline.Lead, identify and implement device product development tools and strategies. Understand how to identify and make decisions related trade-offs of cost, time and performance.
- Provides technical and operational input into the device product development strategy and product life cycle planning.
- Identify and recommend product development investment opportunities to support the Business Unit product pipeline.
- Collaborate with Manufacturing Engineering on the design and selection of tooling and production equipment for successful transfer of new products to manufacturing.
- Proactively identify and escalate risks and issues to relevant stakeholders; lead development and delivery of tactical and achievable mitigation and contingency planning. Lead teams in use of ongoing risk management & communication tools.
- Prepare risk mitigation plans and cost-effective strategies to ensure delivery of new products within time, cost and quality constraints.
- Lead the creation of inventions that will enhance and grow the Emergent intellectual property portfolio through patents and trade secrets.
- Thorough knowledge of ISO 13485 Design Control and ISO 14971 Risk Management for Medical Devices essential.
- Experience in the application of Human Factors and Usability Engineering in medical device design is strongly preferred, including a working knowledge of the components of AAMI/ANSI HE75 and IEC 62366.
- Knowledge of Good Manufacturing Practices (cCMPs) 21 CFR part 820 preferred.
- Maintain Design and Process FMEAs and other risk management tools in accordance with ISO 14971 and other applicable regulations.
- Responsible for development and implementation of Engineering Change system
- Maintain Design History File
- Oversee evaluation of changes (component, product, process) pre-design transfer.
- Support and guide Regulatory Affairs and Quality Assurance with Regulatory Submissions
- Development of Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (Design Verification and IQ/OQ/PQ), and Summary Reports.
- Collaborate with Quality and Compliance during audits, in accordance with CFR 820 and other applicable global regulations
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
- Candidate must possess a minimum of a Bachelor's or advanced degree in Biomedical, Mechanical, Chemical or Materials Engineering (or a related engineering discipline) is required. Master’s degreepreferred.
- 15+ years experience in medical device design and development, including multiple successful product launches (at least 3 significant new product launches preferred).
- Demonstrable knowledge of drug delivery devices including auto-injectors, injection pens, reconstitution and dissolution devices, patch/pumps, pre-filled syringes, inhalers or other novel injection technologies is preferred.
- Thorough knowledge of quality systems, verification, validation, design transfer, and quality engineering principles for medical devices and combination products
- Thorough knowledge of industry standards and FDA regulatory guidance on combination products and medical devices; specialized knowledge in auto injectors or similar drug delivery systems is preferred.
- Strong communication skills both verbal and written including ability to present to Sr. Management and global Health Authorities in support of GMP audits, regulatory approvals, customers/suppliers/sub-contractors, etc
- Experience with part and assembly design utilizing injection molding and associated tooling, materials and machinery.
- Experience with glass and metal stamping components is preferred.
- Demonstrated ability to create and execute to technical plans and timelines in MS Project.
- Proven track record leading technical teams of varying size and make-up (including global and multi-lingual).
- Experience managing and mentoring other engineers and technical staff.
- Track record of creating and managing team and/or department-level budgets.
- Is flexible on work hours and travelrequired to support product development activities with global customers, suppliers and sub-contractors.
- Proficient data analysis skills and mastery of statistical tools in problem solving
- Strong working knowledge of computer-aided design and analytical techniques (SolidWorks or equivalent, COMSOL or equivalent, etc)
- Track record of successfully working with and managing third-party engineering design sub-contractors is strongly preferred.