A global medical device company in Branford, CT is looking to identify a Sr. Engineer
(Manufacturing/R&D Processes) to provide support and oversight of new product development manufacturing engineering for a class III, implantable device for the company's comprehensive portfolio of treatments for structural heart disease within the Surgical BU.
The Senior Engineer will support the Global Supply Chain Network by managing engineering activities from early product development through product launch. This role is accountable for successful commercialization of new products. The Senior Engineer will also ensure that design and manufacturing processes are characterized, robust, scalable utilizing best technologies, reflect standard work, are capable and compliant with Regulatory requirements and are validated for Design Control, Manufacturing using LEAN Six Sigma, Design for Manufacturing and Design for Cost Methodologies.
The Senior Engineer will act as a liaison between R&D, Supplier Development, Quality and Operations team members assigned to the project. The position will report to the Manager of Operations Integration, New Product Introduction.Duties:
- Operations technical leader for new products in the PDP process and its main interface between R&D, Pilot, and commercial manufacturing
- Support operational transitions through development, clinical, and commercialization phases and ensure completion of Design Transfer
- Responsible for the development of applicable Process Development (IQ/OQ/PQ) protocols and provide support for execution of validation plans and reports
- Manage pilot production builds, planning, tracking and execution
- Drive the development and manage the execution of complex experiments and tests (including writing an executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports
- Responsible for Characterization and Validation activities, including CTQ flow-down and identification of critical control points within manufacturing
- Leads development of pFMEA
- Act as the liaison between Contract Manufacturing Organization (CMO), and the company to co-ordinate manufacturing activities as directed by the Manager of Operations Integration
- Deploy manufacturing risk assessment and mitigations, including hands on and resourceful action plans
- Responsible for part/drawing release, and accuracy of the Bill of Materials (BOM)
- Review engineering product specifications, CAD data/drawing, as part of design review process to ensure they meet industry and manufacturing standards and practices
- Ensure DFM, Six Sigma, and LEAN considerations are incorporated into product and process designs, including design and process 3P
- Provide analysis and track progress against agreed upon targets and deliverables.
Education & Experience:
- Technical expertise in the area of manufacturing engineering: design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience, cGMP, EH&S guidelines, supplier development engineering and process validation required.
- Proven track record in design transfers to Operations and process, equipment validation experience
- Understand injection molding, polymers and commonly used materials in the medical device space, such as Nitinol and implantable, with working knowledge of metals processing
- Experience in developing process requirement specifications, collaborating with external parties, and working with Operations personnel to establish efficient solution systems
- Excellent communication and interpersonal skills at all levels of employees including upper management, suppliers, operators and external parties.
- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.
- A bachelor's degree in a related field such as mechanical, manufacturing, or industrial engineering required.
- Minimum of four years of medical device manufacturing experience is required.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
New Product Development