Senior Process Engineer - Columbia, United States - Aztec

Aztec Columbia, United States

2 weeks ago

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 Senior Process Engineer 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 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 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

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.

Support the conversion of small scale processes into commercially viable operations including documentation, equipment, and process development.
Evaluate, implement, and monitor processes and equipment for the manufacture of medical products.
Lead continuous improvement programs by implementing measures to improve production methods, equipment performance, and quality of product.
Function as the manufacturing lead for process validation and process monitoring.
Author & review 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
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

DESIRED MINIMUM QUALIFICATIONS

Education & Experience:
Bachelor's degree in Chemical Engineering, Mechanical Engineering, or related engineering discipline.
Minimum of 5 – 7 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
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.

SUPERVISION RECEIVED
Low

SUPERVISION EXERCISED
This position does not include direct reports.
Travel Requirement (% percentage)

5% – 10% travel required

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.

This site is governed solely by applicable U.S. laws and governmental regulations.

If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law

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EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the

ADA
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