Senior Product Development Engineer

Position Summary

The goal is to develop products, define specifications, and establish reasonable timelines while developing high-quality products that meet the end-users expectations. Relies heavily on meeting dates, while using experience and judgment to develop products and meet goals with minimal supervision. 

Responsible for responding to Requests for Quotes, managing quick turn medical device OEM projects, and prototyping surgical suture and subassemblies. Candidate must be able to work with minimal supervision in a fast-paced, customer-centric environment; should enjoy communicating with customers, vendors, and internal departments; and be passionate about our goal of consistent on-time delivery of high-quality products.

This position is ideally suited for experienced Engineers that like to roll up their sleeves and spend time on the production floor. Typical projects last a few weeks, not months, so the position is a good fit for Engineers who enjoy autonomy and quick results from their efforts; less suitable for those who prefer managing long-term projects and delegating tasks to team members.
 

Principal Responsibilities

•    Manage direct reports, establish staffing requirements, and acquire necessary resources when needed to complete projects on time and within budget.
•    Hands-on surgical suture design, development, and manufacturing. 
•    Accurately predict project costs, material lead times, and product delivery schedules during the quoting process, and utilize the SAP system to support project needs
•    Develop bills of materials and assembly method, update SAP, and provide any needed training to technicians and assemblers.
•    Develop custom devices, sutures and subassemblies according to customer design, performance, and quality specifications; on time and within budget.
•    Develop products and processes that are reliable as well as identify risks to the project, develop contingency plans, while outlining deliverables and milestones
•    Directs and coordinates production activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification
•    Review and prepare status reports, modify schedules, and project plans as required
•    Keeps stakeholders, customers, and others informed of project status and/or related issues
•    Provide technical leadership, root cause analysis, and resolve customer or project-related problems; materials, assembly, functional, or manufacturing related
•    Apply design controls from initial customer requests throughout the products' life cycle
•    Writing, monitoring, managing, and reviewing protocols, including verification and validation tests, ECN, SOP's, BOM's, drawings, and may include calculation and/or FMEA etc. as required to develop, support, or maintain technical documentation
•    Intimately involved in developing protocols, including verification and validation testing, drawings, calculation and/or FMEA etc. to develop and support technical documentation
•    Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans
•    Address customer's issues: improve performance, appearance, and impact on end-user
 

Education / Experience Requirements

•    Bachelor's degree required, preferably in Engineering or other related field 
•    Minimum of 8 years experience in Medical Device Design Development  
 

Specialized Skills / Other Requirements

•    Working knowledge of manufacturing processes related to medical device manufacturing
•    Ability to prioritize and work independently as a self-starter with strong proactive work ethics
•    Experience with design controls, FDA regulation, MDD, and QSR requirements.
•    Proficient in Microsoft Office and Microsoft Project
•    Excellent working knowledge Solid Works 
•    Experience with Risk Analyst tools and procedures
•    Proven track record in Leadership role and utilizing Project Management
•    Proven track record in product development, design, and working closely with manufacturing
•    Demonstrated customer relations, problem-solving, and product development skills
•    Ability to influence across boundaries, drive collaboration, and develop product to meet the end-users expectations
•    Must be well-organized, detail-oriented, with excellent oral and written communication skills