Project Engineer II

BioDLogics LLC; Cordova (TN); On-site; USD 62,000 - 85,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k)

Job summary

Integra LifeSciences is seeking a Project Engineer II in the US to coordinate capital projects, manufacturing support, and continuous improvements under engineering leadership.

You will collaborate with Production, Quality, R&D and suppliers, drive change controls and root cause investigations, and lead process transfers to production with travel 5–10%.

Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering or related field.
• 3+ years of engineering experience; medical device experience is a plus.
• Lean Six Sigma experience is a plus.
• Cleanroom manufacturing experience is a plus.

Responsibilities

• Provide project management for capital projects, continuous improvement, design transfer and system projects.
• Lead continuous improvement to improve production methods, equipment performance, and product quality.
• Evaluate and monitor processes and equipment for medical product manufacture; lead process validation and monitoring.

Skills

Project management

Root cause analysis

PFMEA

cGMP

Change control

Statistical analysis

Lean Six Sigma

Education

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related engineering discipline

Tools

CAD (SolidWorks)

Minitab

SCADA

CMMS

Job description

Changing lives. Building Careers. Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Project Engineer II 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 the change management program. The 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 project engineer will work within cross-functional core teams on the development of new products and processes ensuring on-time transfer of new products and processes to production.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provide project management for capital projects, continuous improvement projects, design transfer projects, and system projects (SCADA, AI, CMMS, ect...)
• Lead continuous improvement programs by implementing measures to improve production methods, equipment performance, and quality of product.
• Evaluate, implement, and monitor processes and equipment for the manufacture of medical products.
• Function as the manufacturing lead for process validation and process monitoring.
• Author & review IQ, OQ, and PQ protocols in addition to 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.
• Investigate process & equipment failures, work with production to determine root cause, and implement corrective and preventative actions.
• Additional Responsibilities Interface with procurement to identify and evaluate new and replacement raw materials.
• 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.
• Mentor junior engineers on cGMPs and good engineering practices, as applicable.

Travel Requirement (% percentage)

5% - 10% travel required

DESIRED MINIMUM QUALIFICATIONS

• Education & Experience: Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related engineering discipline.
• Minimum of 3 years of industry experience in engineering; medical device industry experience is a plus.
• Lean Six Sigma Experience is a plus.
• Cleanroom manufacturing experience is a plus.

Computer proficiency Required

Demonstrates strong work ethic and job performance in both independent and collaborative settings. Demonstrates competence in performing/leading root cause investigations. Demonstrates competence in initiating & leading manufacturing changes through change control. Demonstrates understanding of design control. Demonstrates ability to author technical and controlled documents for engineering, such as study reports and SOPs. Demonstrates competence in specific applicable engineering disciplines. Demonstrates ability to work & deliver results independently Demonstrates leadership in groups and teams. Demonstrates ability to plan & schedule work in order to deliver on small - medium project timelines (up to ~1 year) Communicates effectively with management and peers. 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. Experience leading and implementing smaller cross-functional projects. Ability to manage multiple projects and tasks simultaneously Excellent analytical thinking and technical writing skills

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

SALARY PAY RANGE

$62,000.00 - $85,000.00 USD

Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.

ADDITIONAL DESCRIPTION FOR PAY TRANSPARENCY

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
• Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

EEO Statement

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 | 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. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].

UNSOLICITED AGENCY SUBMISSION

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

Employer Branding

Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.