Staff Process Engineer Design Transfer Center of Excellence

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 whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Process Engineer Design Transfer - Operations Center of Excellence (CoE) reporting to the Director Global Operations Excellence CoE is a position responsible for establishing governing and scaling bestinclass manufacturing transfers and processes across a global life sciences manufacturing network. This role integrates design control process development process validation and supplier/technology strategy to drive safe compliant scalable and costeffective operations.

KEY RESPONSIBILITIES

• Work in and lead cross-functional project teams including R&D Quality Supplier Quality Procurement Planning Regulatory and Manufacturing to develop and transfer surgical products for the neurosurgical medical device industry.
• Recognized manufacturing process technical expert who can independently provide engineering knowledge and oversight to plan and develop manufacturing processes identify spec and procure mfg equipment develop operation plans to support product development and transfer resolve manufacturing- and quality-related problems and interface with production facilities to act as the Voice of Operations on projects.
• Interprets internal/external manufacturing challenges and applies best practices to improve processes and capabilitities.
• Leading manufacturing transfer workstreams and teams including developing and executing project plans and milestone controlling / adjusting project plans; developing alternate pathways or options; identifying and mitigating technical and project risks; presenting project status to management standardizing procedures across sites.
• Partnering with suppliers and internal manufacturing engineering teams to develop new processes and to refine current manufacturing processes review output of those processes and make corrections where needed to improve robustness. Review may include activities such as process mapping sampling controlled design of experiments and component inspections/test method development and validations.
• Provide leadership (technical and business) on critical supplier related programs to ensure stable supply and support the overall supplier relationship.
• Developing and transferring control plans and monitoring processes at internal and external manufacturing sites to ensure processes are controlled and stable.
• Proactively and independently manages priorities based on changing needs; adjusts priorities to minimize impact to other business needs; communicates priorities as appropriate.

REQUIRED SKILLS & MINIMUM QUALIFICATIONS

Education

• Bachelors degree with 10 years of experience or M.S with 7 years of experience is required.
• Masters degree preferred.

Experience

• Experience in the medical device industry is strongly preferred.
• Minimum of 5 years of Project Management experience is required PMP certified preferred.
• A broad knowledge of manufacturing processes and subject matter expertise in specific manufacturing areas is required. Process expertise applicable to medical device manufacturing is strongly preferred.
• Design experience relating to manufacturing transfer of new products and knowledge of the full product life cycle is required along with the ability to manage large/complex transfers with minimal oversight.
• Advanced knowledge in the application and selection of manufacturing processes with specific technologies is strongly preferred.
• Proficient knowledge of Process Excellence / Six Sigma statistical analysis techniques and its application in manufacturing processes is strongly preferred.
• Knowledge of GD&T standards is strongly preferred.
• Knowledge of how to execute GMPs ISO 13485 Design Control and manufacturing process IQ OQ PQ qualifications as related to medical devices is required.
• Strong technical communication skills and demonstrated ability to work independently with external suppliers is required.
• This position will require up to 10% travel.

Skills & Competencies

• Strong organizational interpersonal and communication skills. Ability to present at management and leadership level meetings.
• Proficiency in MS Office Suite and statistical analysis software (ie minitab).
• Familiarity with health safety and environmental regulations related to manufacturing.
• Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.
• Business understanding and wide systemic view
• High analytical skills both financially and technically

Tools And Equipment Used

This role requires regular use of tools and equipment relevant to the work environment. Examples include:

• General office equipment: Computers printers copiers fax machines and telephone communication systems.
• Testing and diagnostic equipment (for service repair or production roles): Data loggers thermocouples pressure indicators and other measurement or calibration tools.
• Additional tools may vary depending on the specific function (e.g. manufacturing field service or laboratory work) and will be defined in role-specific documentation.

Salary Pay Range:

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. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

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 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 youd 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

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 candidates name resume or background) are position-specific and may only occur within the scope of that approved agreement. Please no phone calls or emails.

Integra - Employer Branding from Integra LifeSciences on Vimeo