Senior Manager, Process & Design Development Engineering

Jobtailor; Chelmsford (MA); On-site; USD 140,000 - 200,000; Full time

Job summary

Teleflex is seeking a senior engineering leader to drive process and design expertise for the IAB Catheter portfolio in Acute Care. You will lead a capable team developing new and modified catheters, validation methods and production processes across multiple initiatives.

The role emphasizes IQ/OQ/PQ validation, data-driven decision making, and cross-functional collaboration with Operations and Quality to improve manufacturing and quality outcomes. Domestic travel is expected.

Qualifications

• Minimum 8 years of related experience.
• Medical Device, Pharmaceuticals or other highly regulated industry experience required.
• Expertise in process validation (IQ, OQ & PQ).
• Experience developing processes through various stages of the product development cycle.
• Excellent analytical and problem-solving skills.
• Familiarity with statistical techniques.
• Experience with Design of Experiments.
• Very strong interpersonal and communication skills.

Responsibilities

• Lead a team of engineers providing process and design engineering expertise for the IAB Catheter portfolio within Acute Care
• Manage design, development and implementation of new or modified products, processes, equipment and verification methods for IAB catheters
• Drive data-informed decisions to improve catheter manufacturing processes with Operations and Quality teams
• Coordinate and execute product design improvements, process characterization, Design of Experiments and validation builds
• Identify and coordinate development, sourcing and qualification of equipment, tooling, fixtures and materials
• Serve as product expert/SME and coach best practices across design, development and sustaining activities
• Oversee multiple complex projects and provide supervision and guidance to technical personnel
• Provide input to project plans and timelines, track progress and communicate status
• Write, review and approve technical documentation, including plans, protocols, reports and FMEAs
• Conduct and oversee risk analyses, root-cause investigations, design-related nonconformances and CAPAs
• Develop team-member skills through coaching, training and mentoring
• Participate in strategic and budgetary planning
• Plan organizational resources and budgets
• Oversee manufacturing transfer of new products and transfers to other manufacturing locations
• Ensure project resource commitments, operational deliverables, readiness measures and risks are incorporated into project plans
• Work with Global Supply Chain and Operations leaders
• Ensure projects comply with Teleflex’s Quality system
• Ensure compliance with Teleflex’s Code of Ethics, policies, procedures and housekeeping standards

Skills

Process Validation

Project Leadership

Design of Experiments

Statistical Techniques

Cross-Functional Influence

Analytical Thinking

Mentoring/Coaching

Communication Skills

Education

Engineering degree (Bachelor's)

Advanced degree preferred

Tools

MS Office Applications

Job description

• Lead a team of engineers providing process and design engineering expertise for the IAB Catheter portfolio within Acute Care
• Manage design, development and implementation of new or modified products, processes, equipment and verification methods for IAB catheters
• Drive data-informed decisions to improve catheter manufacturing processes with Operations and Quality teams
• Coordinate and execute product design improvements, process characterization, Design of Experiments and validation builds
• Identify and coordinate development, sourcing and qualification of equipment, tooling, fixtures and materials
• Serve as product expert/SME and coach best practices across design, development and sustaining activities
• Oversee multiple complex projects and provide supervision and guidance to technical personnel
• Provide input to project plans and timelines, track progress and communicate status
• Write, review and approve technical documentation, including plans, protocols, reports and FMEAs
• Conduct and oversee risk analyses, root-cause investigations, design-related nonconformances and CAPAs
• Develop team-member skills through coaching, training and mentoring
• Participate in strategic and budgetary planning
• Plan organizational resources and budgets
• Oversee manufacturing transfer of new products and transfers to other manufacturing locations
• Ensure project resource commitments, operational deliverables, readiness measures and risks are incorporated into project plans
• Work with Global Supply Chain and Operations leaders
• Ensure projects comply with Teleflex’s Quality system
• Ensure compliance with Teleflex’s Code of Ethics, policies, procedures and housekeeping standards

Requirements

• Minimum education engineering/technical bachelor’s degree; advanced degree preferred
• Minimum 8 years of related experience
• Medical Device, Pharmaceuticals or other highly regulated industry experience required
• Expertise in process validation (IQ, OQ & PQ)
• Experience developing processes through various stages of the product development cycle
• Excellent analytical and problem-solving skills
• Familiarity with statistical techniques
• Experience with scientific methods and Design of Experiments
• Very strong interpersonal and communication skills
• Proficiency in leading teams and influencing cross-functionally
• Expertise in project technical leadership and overseeing multiple projects simultaneously
• Ability to understand and resolve complex technical and business system issues
• Ability to coach and mentor managers, engineers, project management colleagues and other professionals
• Proficiency in MS Office applications
• Ability to read and understand technical drawings, product requirements and specification documents
• Flexible and adaptable; excellent time management and prioritization
• Ability to travel domestically

Core Competencies

Demonstrates expertise in process validation, project technical leadership, and cross-functional team influence within the medical device industry. Proficient in managing complex projects, ensuring compliance with quality systems, and developing team skills through coaching and mentoring.

Highest-signal resume keywords

• Process Validation (IQ, OQ & PQ)
• Project Technical Leadership
• Design of Experiments
• Medical Device Industry Experience
• Statistical Techniques

ATS Optimization Keywords

Hard Skills

• Process Validation
• Design of Experiments
• Project Management
• Technical Documentation
• Risk Analysis
• Root-Cause Investigation
• Manufacturing Transfer
• Product Development Cycle
• Analytical Skills
• Technical Drawing Interpretation

Soft Skills

• Interpersonal Skills
• Communication Skills
• Coaching and Mentoring
• Problem-Solving
• Time Management

Industry Keywords

• Medical Device
• Pharmaceuticals
• Regulated Industry
• Quality System Compliance
• Teleflex Code of Ethics

Tools & Technologies

• MS Office Applications