PRODUCT DEVELOPMENT ENGINEERING

TELEFLEX MEDICAL OEM

Due to confidentiality agreements and regulatory considerations, project details are intentionally generalized.

Position Summary: Product development engineer with experience in suture-based medical device design. I lead customer-driven development efforts from early concept through validation, with a focus on design controls, prototyping, and data-driven decision making. I am a strong cross-functional collaborator and problem solver across R&D, quality, and manufacturing teams. I have hands-on experience with DOE, Minitab statistical analysis, and validation testing.

Click to explore each core competency area:

Customer-Driven & Internal Product Development	Suture Design Iteration & Prototype Refinement	Verification, Testing, & Process Characterization

SUTURE-BASED MEDICAL DEVICE DEVELOPMENT

CUSTOMER-DRIVEN & INTERNAL PRODUCT DEVELOPMENT:

Lead engineering contributions across customer-driven and internal suture-based product development programs, translating requirements into manufacturable design solutions within a regulated development environment.

Key Contributions:

Conduct early-stage user needs discussions to assess product requirements, identify technical challenges, and guide development strategy from concept through design freeze
Translate ambiguous or open-ended customer requirements into actionable engineering inputs by identifying functional intent, performance constraints, and manufacturability considerations early in development cycles
Evaluate tradeoffs between performance requirements, manufacturability, and process capability to guide development direction and reduce iterative redesign cycles
Act as the primary engineering lead for customer-driven development programs by managing project timelines, coordinating deliverables, and driving cross-functional execution across manufacturing, quality, and operations teams
Align development strategy across manufacturing, quality, and operations teams to ensure feasibility and consistency of requirements prior to design execution
Manage competing priorities across multiple concurrent customer-driven programs, balancing timelines, resource constraints, and development complexity
Develop and refine custom suture and braid constructions through iterative prototyping, internal testing, and customer feedback to optimize product functionality and manufacturability
Generate engineering deliverables required for commercialization activities, including BOM structures, label content, router definitions, and controlled documentation updates within quality management workflows
Collaborate directly with external suppliers to evaluate new materials, equipment, and development capabilities supporting ongoing product innovation efforts
Contribute to internal research and development initiatives focused on expanding technical capabilities and supporting future product line growth

SUTURE DESIGN ITERATION & PROTOTYPE REFINEMENT:

Lead engineering contributions across customer-driven and internal suture-based product development programs, translating Develop and refine suture and braid architectures through iterative design modifications, leveraging hands-on engineering judgment to optimize performance, manufacturability, and customer requirements.

Key Contributions:

Translate both highly defined specifications and open-ended customer requests into functional prototype concepts through iterative development, engineering evaluation, and manufacturability assessment
Apply practical engineering judgment and hands-on development experience to identify effective starting configurations, reducing iterative development cycles while optimizing braid performance and process feasibility
Develop custom suture and braid constructions by modifying braid architecture, material combinations, fiber sizing, and dimensional characteristics to meet customer-driven product requirements and performance objectives
Rapidly generate and refine prototype configurations using internal testing, material evaluations, and development feedback to efficiently converge on viable product solutions during early-stage development activities
Refine prototype constructions through iterative testing and customer feedback cycles involving evaluation of tensile performance, cyclic fatigue behavior, dimensional consistency, degradation characteristics, and braid structural properties
Utilize off-the-shelf materials and existing braid platforms during exploratory development activities to establish baseline performance and guide customization strategies for new product configurations
Balance product performance requirements, manufacturability considerations, process capability, and development timelines throughout iterative product refinement activities
Support both modification of existing braid constructions and development of entirely new configurations to address evolving customer requirements and internal innovation initiatives
Create detailed technical instructions and execution guidance for operators and technicians to support braid setup, prototype manufacturing, testing activities, and iterative process refinement
Coordinate overlapping prototype development activities across multiple customer-driven programs within fast-paced development timelines and shifting project priorities

VERIFICATION, TESTING, AND PROCESS CHARACTERIZATION:

Execute mechanical testing and data analysis to verify product performance against specifications and characterize process behavior to support development and manufacturing readiness.

Key Contributions:

Develop and execute verification protocols to evaluate performance, functionality, and manufacturability of custom suture and braid constructions throughout iterative development cycles
Conduct and coordinate mechanical and material testing activities including tensile, cyclic fatigue, dimensional, degradation, endotoxin, and braid characterization testing to assess product performance and process consistency
Analyze development and verification data using Minitab to evaluate specification compliance, assess process capability, and support development decision-making for new and existing braid constructions
Author technical reports documenting testing methods, engineering observations, statistical analyses, and development conclusions to support customer-driven and internal product programs
Author Performance Qualification (PQ) protocols and reports to support process validation and transition development programs toward manufacturing readiness
Support specification development activities by evaluating prototype performance data, process variability, and manufacturability considerations during early-stage product development
Design and execute small-scale Design of Experiments (DOE) studies to evaluate development variables and support process optimization activities for internal research and development efforts
Create and refine testing methodologies and acceptance criteria for new product configurations and internal development initiatives when existing methods are not available
Collaborate with technicians and operators during testing and execution activities by providing technical guidance, troubleshooting support, and clarification of development procedures and process requirements