INGENYX - Engineer III, Development

Teleflex•Mansfield, MA

7d•$110,500 - $165,800•Onsite

About The Position

The Engineer III, Development is responsible for leading the execution and oversight of engineering projects of varying complexity within the OEM Performance Fibers (sutures) business unit. With a focus on new development projects such as sterile and non-sterile line extensions, new suture constructs, processes and technologies, they are responsible for leading and supporting Development projects with a low level of guidance. They are also responsible for establishing and supporting manufacturing operations including the validation of new equipment and materials, troubleshooting development processes, as well as identifying and implementing process/product improvements within development activities. The engineer will work with cross-functional teams to, resolve material issues, customer complaints, design and develop new product, and review potential new business opportunities. The Engineer III, Development is expected to have a working proficiency in Design Control and development methods, medical device regulations, manufacturing, and project management. They will be expected to successfully carry out and support project deliverables/product development functions with a focus on quality, compliance, and customer needs. The scope of products for which the Engineer III, Development will be primarily responsible for developing and supporting includes sterile and non-sterile suture components, contract manufactured suture products, and sterile suture devices for the Mansfield, MA, Coventry, CT, and Nuevo Laredo, MX facilities.

Requirements

Bachelor of Science in an Engineering or related technical discipline.
Minimum 4 years of experience in medical device or related field (5+ years preferred).
Minimum of 4 years of experience successfully leading projects and/or project deliverables (5+ years preferred).
Knowledgeable in U.S. FDA GMP and ISO requirements for the design, validation, and manufacturing of medical components and/or devices.
Experience with customer facing interaction is highly preferred.
PMP certification is a plus.
Through a strong foundation of experience, is versed in design controls and capable of effectively managing development and project activities to achieve expected outcomes.
Can effectively manage direct reports (as applicable) with moderate guidance and shows good judgement in leadership skills.
Is able to contribute to identifying project and organizational needs and uses "big picture" thinking in troubleshooting.
Approaches opportunities with a constructive “can-do” attitude.
Is able to effectively influence positive action independently as well as within direct reports (as applicable).
Shows ability to see "big picture" and can anticipate cross functional challenges/respond to them.
Operates at a mostly autonomous level to meet goals and operational targets.
Shows strong logic and judgement when identifying risks and opportunities. Can formulate strong action plans based on experience and engineering knowledge.
Automatically takes ownership for the outcome and informally works with peers and associates to ensure the outcome occurs on the company's behalf.
Strong reputation as a team player and exhibits leadership skills.
Demonstrates skill in positively resolving conflict in individual and group settings. Sets example for positive interactions and constructively dealing with conflict.
Ability to propose credible solutions to customers and explain the value proposition offered by Teleflex Medical OEM.
Capable of quoting and coordinating quoting efforts across a multiple engineers. Demonstrates ability to use entrepreneurial thinking when conceptualizing quotes.
Exhibits the determination and curiosity to solve problems. Employs a systematic structured approach. Can suspend judgement and avoids jumping to conclusions.
Demonstrates willingness to share skills and takes the time to mentor the people effectively.
Demonstrates ability to effectively guide team towards customer focused activities and solutions.
Shows a functional understanding of the quality system and is able to navigate it effectively, showing good judgement in risk assessment and decision making where the quality system lacks specific detail.
Exercises excellent discretion and independent judgement.
Focused on detailed work with emphasis on accuracy and completeness.
Strong organizational and planning skills; drives for results.
Ability to perform in-depth analysis of complex issues or situations to develop solutions.
Ability to handle multiple tasks of varying complexity and to prioritize/schedule work to meet project needs with little supervision.
Experience with Microsoft Office – PC, Word, Excel, PowerPoint, Project (or similar).
Working knowledge of project management principles and methodology.
Working knowledge of international regulations, requirements and/or ISO 13485 quality systems.

Nice To Haves

5+ years of experience in medical device or related field.
5+ years of experience successfully leading projects and/or project deliverables.
PMP certification is a plus.

Responsibilities

Plan, lead and manage projects and manufacturing engineering activities of moderate to low complexity independently. Manage complex projects/programs with some guidance.
Lead development of products that minimize/mitigate product and manufacturing variation, scrap rates, and productivity throughout the manufacturing process, from supplier management to distribution of product.
Develop custom devices, sutures and subassemblies according to customer design, performance, and quality specifications; on time and within project constraints.
Identify and manage the scope of projects with a good understanding of interdependencies.
Draft and route project initiation/closure documents, identifying the required deliverables per local and global procedures, as well as governing regulations, with minimal guidance based on project complexity.
Interface with cross functional teams to maintain accountability, coordinate and execute deliverables supporting new product and capability development projects, and other initiatives.
Serve as central contributor to identification and execution of continuous improvement initiatives.
Accurately predict project requirements, costs, lead times, and delivery schedules during the quoting and project execution processes.
Apply structured project management principles such as scope definition, timeline development, contingency planning, risk planning and mitigation, stakeholder analysis, et cetera, to plan, lead and execute projects of low to high complexity.
Lead quoting exercises such as component sourcing, identification of project deliverables and risks, and timeline estimation, of low to high complexity with minimal guidance.
Review and prepare status reports, modify schedules, and project plans of high complexity as required.
Manage stakeholder communication to ensure project status and/or related issues are effectively communicated. Collaborate with sales and customer care to support customer communications.
Utilize and integrate lean principles within project, process, and resource management activities, acting as a catalyst for initiating change.
Serve as key resource in design control and product capabilities to effectively lead and support Performance Fibers projects and initiatives.
Ensure Teleflex Medical OEM suture products meet customer and quality system requirements.
Provide technical leadership, lead root cause analysis and customer or project related problem resolution activities; materials, assembly, functional, or manufacturing related.
Possess detailed understanding of design control requirements and identify strategies to achieve project and business goals independently, or with little guidance.
Maintain a strong understanding of product capabilities to support Performance Fibers projects and initiatives.
Review and create product/customer specification documents based on internally validated specifications and inspection criteria.
Generate validation and verification protocols/reports, draft and review product labeling, initiate and manage sterility and biocompatibility assessments as well as other design control related documents independently.
Effectively establish validation and development plans of moderate complexity with a minor level of guidance.
Utilize methods of Lean/6σ and other continuous improvement methods for factory improvement programs such as Enterprise Excellence.
Support and lead root cause analysis investigations, NC’s and CAPA’s and customer or project related problem resolution activities.
Coordinate and support proper creation and maintenance of drawings, procedures, design documents (DFMEA, FMEA, Traceability Matrix, etc) as well as other technical and manufacturing documentation.
Assist in establishing continuous improvement initiatives and methods of application.
Utilize understanding of medical device development and product line fundamentals to develop project strategies of moderate complexity.
Contribute to creation/remediation of new processes, methods and techniques.
Ensure projects are developed and documented compliant with the Quality System.
Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans.
Lead and support design control reviews with minimal guidance.
Support and/or lead EPIC Medtech customer visits and activities as needed.
Represent Teleflex Medical OEM on calls in relation to opportunities as an SME.
Support external and internal audits.
Guide and mentor peers and less senior team members.
Lead and guide direct reports (as applicable) to successful completion of projects and tasks.
Overall management of direct reports (as appliable).
Support the individual development of direct reports (as appliable).
Coach and mentor direct reports (as applicable) and peers in challenges and opportunities for learning to support overall team/value stream success.
Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
Other responsibilities as required.