Sr. Engineer, Process - Columbia, United States - Integra LifeSciences

Description

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

The Sr. Engineer, Process will coordinate with Production, Quality, Research & Development, and external suppliers to manage capital projects, manufacturing support, and continuous improvements under guidance of engineering leadership within the constraints of domestic and foreign Medical Device Regulations. The employee will investigate, determine root cause, and implement corrective and preventive actions for manufacturing quality issues. The engineer will initiate and lead the implementation activities for changes approved within Integra's change management program. The Sr. Process Engineer will also manage and drive capital projects including design, build, commissioning, and qualification, ensuring the proper goals and milestones are met on time and within budget. The Sr Process Engineer will work within cross-functional core teams on the development of new products ensuring on-time transfer of new products to production. This is an individual-contributor position.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Lead investigations for product, process, and equipment non-conformances and CAPAs.
• Lead continuous improvement changes by implementing measures to improve production methods, equipment performance, and quality of product.
• Evaluate, implement, and monitor equipment for the manufacture of medical products.
• Function as the manufacturing lead for process validation and process monitoring.
• Author, review, and execute IQ, OQ, and PQ protocols in addition to performing process validations
• Provide key technical and project management support in capital projects
• Utilize Process Failure Mode and Effects Analysis (PFMEA) and Design Of Experiments to analyze manufacturing processes.
• Test protocol generation, execution, and reporting.
• Responsible for specific departmental functions, and performance metrics, as applicable
• Contribute to department strategy and budget planning.

Additional Responsibilities

• Participate in design reviews with the product development teams
• Act as the manufacturing technical lead for new product development projects, supporting process development and validation activities as well as product launch and build planning in production, as applicable.
• Interface with procurement to identify and evaluate new and replacement raw materials.
• Mentor junior engineers on cGMPs and good engineering practices, including review of technical documentation.
• Ensure proper documentation is completed to meet quality system requirements
• Assist with the preparation and completion of cost estimates, reports, forecasts, schedules, and budgets.
• Interface with others in the organization to ensure deadlines, quality requirements, and production metrics are met.

Travel Requirement (% percentage)

• 5% - 10% travel required

DESIRED MINIMUM QUALIFICATIONS

Education & Experience:

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, or related engineering discipline.
• Minimum of 1-3 years of industry experience in engineering; medical device industry experience is a plus.
• Significant leadership and mentoring experience is required.
• Experience leading and implementing significant cross-functional projects.
• Experienced in transferring and launching new products in manufacturing, medical device experience in design control is a plus.
• Lean Six Sigma Experience is a plus.
• Computer proficiency

Required Knowledge, Skills, and Abilities

• Ability to manage multiple projects simultaneously, including task delegation.
• Excellent analytical thinking and technical writing skills
• Communicates effectively with management and peers.
• Demonstrates ability to plan & schedule work in order to deliver on both small and large project timelines (multi-year timelines, multi-depertment resourcing).
• Demonstrates competence in performing/leading root cause investigations.
• Demonstrates competence in initiating & leading manufacturing changes through change control.
• Demonstrates comprehensive understanding of the elements of design control.
• Demonstrates ability to author, review, and approve technical and controlled documents for engineering, such as study reports and SOPs.
• Demonstrates competence in all applicable engineering disciplines.
• Demonstrates ability to work & deliver results independently
• Demonstrates leadership in groups and teams.
• Proficiency in statistical analysis such as tolerance interval analysis, capability analysis, hypothesis tests and design of experiments.
• Project Management skills including critical path identification, delegation, risk management, stakeholder management, and effective communication are required.
• Demonstrates exceptional competence in all applicable engineering disciplines.
• Demonstrates ability and initiative to mentor Associate / Staff engineers

TOOLS AND EQUIPMENT USED

• Typical office equipment (computer, phone, etc)
• Lab equipment: Comfortable using engineering measurement devices: multi-meter, thermal mapping, data loggers, etc.
• Software: familiarity with CAD (i.e. solidworks) and statistical analysis (i.e. minitab).

PHYSICAL REQUIREMENTS

• Ability to view computer screen for extended periods
• Must be able to stand and/or sit for extended periods of time
• Must be able to move between manufacturing areas

ADVERSE WORKING CONDITIONS

• Open office work area with light to moderate noise
• Able to work in a cleanroom/ controlled environment with gowning

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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