Job Title: Principal Process Development Engineer

Department: Operations

FLSA Status: Exempt

JOB SCOPE AND DIMENSIONS:

Job Summary: This position is responsible for leading the development of manufacturing processes and equipment technologies to enable high-quality manufacturing of catheter-based medical devices including stents, stent delivery system, and embolic protection devices.

Receives Direction From: Director of Process Development

Process Development Engineering Manager

Provides Direction To: Manufacturing Technicians

Production Supervisors

Typically responsible for supervision of engineers. Works under minimal supervision. May be responsible for project work that includes overseeing other departmental personnel in the implementation of new or modified equipment or processes. May be necessary to coordinate the activities of support groups.

Examples of Essential Functions: Including but not limited to:

Leads the development of highly capable manufacturing processes for new and existing products through frequent interaction with R&D, Manufacturing and Quality Engineering, and Production Operations Leads the innovation and development of new processing technologies. Drives cost reductions and the creation of new technical competencies.

Develops and coordinates the execution of process characterization and validation plans.

Leads continuous improvement projects.

Ensures all Process Development Engineering elements of the PDP for new products meet the needs of each group within operations.

Provides mentoring for more junior technical staff.

Comply with applicable FDA and international regulatory laws/standards and the ev3 Code of Conduct.

Other duties as assigned or required

QUALIFICATIONS GUIDELINES: Any combination equivalent to, but not limited to, the

following:

Education/Training/Experience: Bachelor’s degree in engineering or related field with

eight to twelve years of relevant work in the medical device industry or 6-12 years experience with an applicable MS degree.

Knowledge/Skills/Abilities: Basic reading and engineering level math

Reading and producing drawings

Equipment and tooling design

Experience with design and process FMECA, Process

Validation and variability reduction applications.

Experience with balloon catheter and / or guide catheter production processes preferred.

Good verbal and written communication skills.

Application of statistical and analytical methods such as SPC, SQC, and DOE.

Process background (development, capability, optimization, validation) within a regulated industry.

Development of manufacturing documentation (MP, IP, BOM)

Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design)

Leadership in project teams tasked with new process/product development and the successful transfer into manufacturing.

Manufacturing continuous improvement support

Test protocol generation, execution, and reporting

Excellent written and verbal communication skills

Computer literate; word processing, spreadsheets,

AutoCad

GMP and ISO 9000 training

Recognize problems and take corrective measures

Previous experience developing Nitinol products and processes, either in manufacturing or R&D

Previous supervisory experience

Physical Requirements: Standing

Sitting

Walking

Stairs

Light lifting

Manual dexterity

Direct exposure to health and safety hazards associated

with production materials and equipment

Computer operation

Travel by air, auto, rail

TRAINING REQUIREMENTS Training relative to Company requirements and

procedures and individual job duties will be provided as

outlined on the attached Training Requirements form.

A training file containing documentation of all training

received is maintained for each employee.