INGENYX - Engineer III, Development

Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026. Ingenyx is a leading global provider of product development and production services for medical device manufacturers, specializing in extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins.

About the role

The Engineer III, Development leads the execution and oversight of engineering projects within the OEM Performance Fibers (sutures) business unit. This role focuses on new development projects, including sterile and non-sterile line extensions, new suture constructs, processes, and technologies, with responsibility for project leadership, manufacturing support, validation, troubleshooting, and process improvements. The engineer collaborates with cross-functional teams to resolve material issues, address customer complaints, develop new products, and evaluate business opportunities.

Expected travel: Up to 25%. Primary scope includes sterile and non-sterile suture components, contract-manufactured suture products, and sterile suture devices for facilities in Mansfield, MA; Coventry, CT; and Nuevo Laredo, MX.

Responsibilities

• Plan, lead, and manage projects and manufacturing engineering activities of moderate to low complexity independently; manage complex projects with some guidance.
• Develop products that minimize variation, scrap rates, and productivity issues throughout the manufacturing process.
• Design custom devices, sutures, and subassemblies according to customer specifications, ensuring on-time delivery within project constraints.
• Identify and manage project scope, including interdependencies, and draft project initiation/closure documents with minimal guidance.
• Interface with cross-functional teams to coordinate and execute deliverables for new product and capability development.
• Serve as a central contributor to continuous improvement initiatives and apply structured project management principles (e.g., scope definition, risk planning, stakeholder analysis).
• Lead quoting exercises, including component sourcing, risk identification, and timeline estimation for projects of low to high complexity.
• Prepare status reports, modify schedules, and manage stakeholder communication to ensure effective project updates.
• Collaborate with sales and customer care to support customer communications and propose solutions with a clear value proposition.
• Provide technical leadership in root cause analysis and problem resolution for materials, assembly, functional, or manufacturing issues.
• Ensure compliance with design control requirements and develop validation/verification protocols, product labeling, sterility assessments, and biocompatibility documentation.
• Establish validation and development plans of moderate complexity with minimal guidance.
• Utilize Lean/6σ and continuous improvement methods for factory improvement programs.
• Support and lead root cause analysis, non-conformances (NCs), CAPAs, and customer-related problem resolution.
• Coordinate creation and maintenance of technical and manufacturing documentation (e.g., drawings, procedures, DFMEA, FMEA, Traceability Matrix).
• Develop project strategies, remediate processes, and ensure compliance with the Quality System.
• Collaborate on quality assurance, testing, regulatory compliance, and quality plans.
• Lead and support design control reviews, EPIC Medtech customer visits, and external/internal audits.
• Guide and mentor peers, less senior team members, and direct reports (as applicable) to ensure project success.
• Adhere to company policies, procedures, and housekeeping standards.

Requirements

• Bachelor of Science in Engineering or a related technical discipline.
• Minimum 4 years of experience in medical device or related field (5+ years preferred).
• Minimum 4 years of experience leading projects and/or project deliverables (5+ years preferred).
• Knowledge of U.S. FDA GMP and ISO requirements for medical device design, validation, and manufacturing.
• Experience with customer-facing interactions is highly preferred.
• PMP certification is a plus.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project or similar).
• Working knowledge of project management principles and ISO 13485 quality systems.

Skills

• Strong foundation in design controls and project management with the ability to achieve expected outcomes.
• Leadership skills, including managing direct reports (as applicable) with moderate guidance and fostering a constructive, "can-do" attitude.
• Ability to anticipate cross-functional challenges and respond proactively with "big picture" thinking.
• Autonomous problem-solving with strong logic, judgment, and risk assessment capabilities.
• Entrepreneurial mindset for conceptualizing quotes and proposing credible solutions to customers.
• Systematic, structured approach to troubleshooting and problem resolution.
• Mentorship skills, including willingness to share expertise and guide teams toward customer-focused solutions.
• Functional understanding of quality systems and ability to navigate them effectively.
• Strong organizational, planning, and analytical skills to handle multiple tasks of varying complexity.
• Excellent discretion, independent judgment, and focus on accuracy and completeness.

Working Conditions

• Office/Professional and Plant/Manufacturing environments.
• Travel required: Up to 25%.

Pay

The pay range for this position at commencement of employment is expected to be between $110,500 - $165,800. Base pay may vary depending on market location, job-related knowledge, skills, and experience. The total compensation package includes benefits such as medical, dental, vision, and prescription drug insurance; flexible spending accounts; 401(k) savings plan; and paid time off (e.g., PTO, short- and long-term disability, parental leave).