About the Role

We are looking for an experienced Process Engineer to join our Surgical Solutions New Product Development team. This role will support process/product development activities including process design, qualification, and validation in collaboration with a cross-functional team. 

This position will be located at our facility in Elkton, Maryland, with the possibility of a hybrid work arrangement.

Pay and Benefits:

• $95,000 - $142,000 per year
• Factors considered in extending an offer within this pay range include (but not limited to) education, experience, knowledge, skills, and abilities.
• Medical, Dental and Vision benefits effective on Day 1 of employment! We offer a comprehensive total rewards package, including competitive benefits.  More details are available at www.gore.com/careers/benefits

Responsibilities

• Provide process design and support for the research & development of new products
• Understand critical process parameters to ensure the process reliably delivers a fit for use product that meets all specifications and customer requirements
• Support and implement new equipment design, development, and validation
• Identify critical uncertainties and apply engineering fundamentals and critical thinking skills to solve technical challenges
• Identify and address opportunities to continuously improve our products and processes; and assess for regulatory, quality, ergonomic, safety, environmental, and cost impact　
• Plan and execute technical work using statistical techniques including Design of Experiments (DoE) and Statistical Process Control (SPC)
• Utilize Gore project practices and lean business tools to effectively prioritize, plan, and drive projects from development to completion
• Effectively collaborate and influence on cross-functional teams including product specialists, supply chain, manufacturing, regulatory, quality, and external partners
• Document and communicate work appropriately within the quality system

Required Qualifications

• Bachelor’s degree in engineering with minimum of 3 years hands-on engineering work experience post graduation
• Experience with equipment qualification (IQ/OQ) and process validation (POQ/PQ)
• Ability to apply engineering fundamentals and statistical tools to equipment and process design, development, optimization, and troubleshooting activities, ensuring processes are capable, robust, ergonomically sound, and aligned with product-level requirements and specifications
• Ability to prioritize, plan, and drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables
• Ability to work independently and collaborate effectively as part of a team, including influencing across functions
• Ability to identify critical issues and failure modes, creating a framework of action to address these issues and assess root cause including effective risk-based decision making
• Ability to apply formal problem-solving techniques to determine root cause of equipment/process issues
• Ability to document, communicate, and present technical work effectively
• Ability to travel up to 10%

Desired Qualifications

• Minimum of 5 years hands-on experience in a R&D or manufacturing environment as a Process Engineer
• Experience developing or transitioning processes from R&D to pilot, to large scale commercial
• Demonstrated ability to work effectively within a regulated medical device quality system

This position offers a hybrid work arrangement in the country from which the Associate is employed.  Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.

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