Statistical Process Control Engineer Jobs in Boston, MA

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The Process Engineer, Change Control - Operations Center of Excellence (CoE), reporting to the Director, Global Operations Excellence CoE, is a position accountable for implementing, governing, and scaling bestinclass manufacturing change control processes across a global life sciences manufacturing network. This role integrates design control, change impact assessment, process validation and control, and PLM integration strategy to drive safe, compliant, scalable, and costeffective operations.

KEY RESPONSIBILITIES

• Work with Enterprise compliance and Quality process lead to support the daily implementation of change controls to maintain processes that meet the compliance / regulatory guidance, while still allowing for effective and efficient integration into our operations.
• Accountable for ongoing process improvements, productivity improvements, and for leveraging lean Six Sigma methodologies to identify and address inefficiencies across the enterprise.
• SME resource that support the engineering teams during the actual daily usage as it applies to the changes within the manufacturing operations
• 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 capabilities.
• Supporting change control 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 resolve process issues 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 process change projects to ensure stable supply and support the overall change implementation.
• Supporting control plans and monitoring processes at internal and external manufacturing sites to ensure changes implemented 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

• Bachelor's degree with 10+ years of experience or M.S with 7+ years of experience is required.
• Master's 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 changes and knowledge of the full product life cycle is required, along with the ability to manage large/complex change projects with minimal oversight.
• 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 Total Rewards | Integra LifeSciences

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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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.

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