Senior Process Development Engineer

Position Summary

Join our dynamic Interventional Urology business unit, where your expertise will play a pivotal role in shaping the future of healthcare. As a key contributor, you will help develop groundbreaking technologies that enhance patients' lives and empower healthcare professionals.
As a member of the development team, the Senior Process Development Engineer will participate in New Product Development projects by developing robust manufacturing processes for new products across our core portfolios.  
Utilizing first-principles thinking and data-driven decision-making, they will ensure these processes produce products that meet design specifications and cost targets. Responsibilities include but are not limited to planning and execution of equipment and process developments. Transfer of processes into production for commercial manufacturing.  In addition to bringing these products to market, the Senior Process Development Engineer will participate in exploratory new technology investigation, design and development to help fuel the Interventional R&D product pipeline.

Principal Responsibilities

•    Plan process development & validation activities for new products based on projected product volume, project timelines, and COGS targets. 
•    Establish project timelines, track progress, manage to the schedule and communicate project status to management and project leader.  Manage tasks and deliverables for multiple projects simultaneously
•    Identify, specify and coordinate development, sourcing and qualification of equipment, tooling, fixtures and component materials to produce product by design specifications.
•    Work closely with the R&D team, if necessary, help with product development work.
•    Execute process characterization and investigations to document key process inputs and outputs and to establish process limits.
•    Generate documentation as outlined in the Process Development process (e.g. PFMECAs, protocols, reports, MPs, Design Transfer reports, etc.) 
•    Leading the process verification and validation activities.
•    Design and develop fixtures and automation as needed.
•    Direct technicians in performing- equipment qualifications, process characterization and qualification builds.
•    Conduct test data analyses including identification of outliers or non-normal data, generating data plots, general statistical analysis, and determination of process capability. 
•    Lead or participate in Failure Analysis, Root Cause investigation, and identification and verification of corrective actions.  Report results to project and functional leadership
•    Train PD technicians, production operators and manufacturing technicians

•    Mentor and direct PD Technicians 
•    Conduct process design, development, and implementation on multiple complex &/or significant projects. 
•    Develop and implement documented procedures to provide easy to follow instructions.
•    Design and develop process flow and layout to maximize production efficiency
•    Identify, propose and pursue improvement opportunities which align with business objectives
•    Actively participate in continuous improvement initiatives to improve production or business process efficiency. 

Education / Experience Requirements

•    A minimum of 8 years of related experience with a bachelor’s degree or 6 years and a master’s degree, or a PhD with 3 years’ experience or equivalent experience. 
•    Experience with ISO13485, MDD, and FDA Quality System Regulations is preferred. Lesser years of overall experience may be acceptable if it is particularly relevant to the assigned Project or if product/process development skills are appropriately developed.

Specialized Skills / Other Requirements

•    Successful track record of process selection, development, and transfer into commercial production.
•    Experienced in process qualification and validation activities including risk assessment, range finding, DOE and creation of process documentation.
•    Able to work in R&D activities as needed.
•    Proficient in CAD design and development with extensive expertise in drawings and GD&T.
•    Demonstrated project management skills and ability to coordinate multiple projects simultaneously.
•    Excellent knowledge of GMP and QSR including Design Control and Process Validation. 
•    Proficiency in process validation (IQ, OQ & PQ), experience with various production processing methods and the product/process development cycle.
•    Proficiency in MS Office applications, strong written and verbal communication skills, ability to read and understand technical drawings, product requirements and specification documents. 
•    Must have strong independent problem-solving skills and have sufficient understanding of statistical techniques to perform data analyses and process capability analyses (familiarity with statistical software such as Minitab preferred).
•    Excellent analytical and problem-solving skills, experience with scientific methods and Design of Experiments.
•    Preferred: 5 years of experience in medical device production or product development. 
•    Preferred: Experience with common disposable medical device manufacturing processes (e.g. molding, reflow, coating, bonding, packaging, sheet metal). 

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Working Conditions / Physical Demands

The pay range for this position at commencement of employment is expected to be between ($140,000-160,000)  however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.