Principal Manufacturing Engineer

Company: Haemonetics
Location: Covina
Posted on: May 28, 2023

Job Description:

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.
Job Details
The Principal Manufacturing Engineer leads the design, development, implementation and validation of advanced manufacturing processes as well as changes to manufacturing processes for the purposes of quality improvement, manufacturing sustainability, cost improvement and new product introduction. Identifies, develops, and validates state of the art process technology to achieve operational improvements for legacy processes and introduces advanced manufacturing technologies to assure new product success at launch. Applies principles of mechanical design and automation while incorporating Six Sigma and Lean Manufacturing values to achieve organizational goals. Works closely across all business units to integrate and harmonize process equipment, processes, and associated infrastructure. Assists Maintenance department to troubleshoot assembly machines and maintains critical manufacturing systems such as sterilizers and heat processor to minimize downtime. Identifies and validates the required control process parameter based on obtained data and best practices. Authors and executes Engineering Study, IQ, OQ and PQ protocol and reports for Equipment and processes.
Essential Duties:

• Act as team member/leader for complex manufacturing projects to ensure successful manufacturing of medical devices through cross-functional collaboration with other stakeholders and departments.
• Ensure that production processes and systems as well as product designs for both existing and new products produce the highest possible quality and lowest possible cost.
• Responsible for driving and implementing multiple improvement programs and following-up on the results achieved, including Quality Monitoring and Actions, Production Efficiency, Improve Assembly Methods, Document and Implement Approved Changes.
• Constantly research for new materials, processing, testing and design techniques, which can be utilized to improve disposables quality, cost and manufacturability.
• Develop disposable products manufacturing methods and equipment that provide products that meet customer needs and can be produced in high volume at low cost by Haemonetics manufacturing sources world-wide.
• Ensure projects are completed on time, and within budget.
• Manage projects in compliance with Haemonetics SOPs by employing techniques such as project plans, product specifications, phase and design reviews, required documentation, test protocols and test reports.
• Communicate proactively, openly, and cooperatively within the department and with management team to keep team informed; provides oral reports, and prepares timely and clearly written status reports, updates, and technical presentations. May be the project leader on Lean/Six Sigma initiatives and Cost Improvement Projects, 5S, Kaizen events.
• Provide necessary technical assistance for the business unit.
• Proactively identifies, communicates, and refers problems or coordination needs to leadership; provides timely detailed background/data to support problem-resolution; seeks guidance as necessary to respond to needs or changes, and quickly assesses requirements to meet target milestones, goals, and deadlines. Takes initiative to offer suggestions for improved methods, processes, products, services, or techniques.
• Translates engineering requirements, and design specifications into the manufacturing process. Interfaces with customers, suppliers, application users, and other technical and support personnel to support efforts.
• Provide technical leadership, trains, and mentors less senior employees to support business initiatives and strategic goals, and evaluates or troubleshoots problems. Transfers knowledge/ technology solutions within or across groups.
• Proposes technical solutions to resolve issues, and evaluates short and long term impact of recommendations made independently, or proposed.
• Learns and applies standards, processes, policies, practices, techniques, and tools throughout the product/system development lifecycle including Standard Operating Procedures (SOP's) and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems.
• Proactively identifies and solves complex problems using specialized engineering principles, tools, data and methods to recognize and formulate problems, collect data through observation and experiment, and forms, tests, and validates hypotheses; efficiently selects and uses laboratory equipment and tools, and clearly documents, communicates, and summarizes technical findings and results for status updates, coordination, and remediation.
• Maintains critical systems such as sterilizers and Heat Processor to ensure no down time and product failure.
• Assists and supports Maintenance and manufacturing to troubleshoot production equipment.
• Authors and executes Engineering Study, IQ, OQ and PQ protocol and reports for equipment and processes.
• Ensures a safe work environment by complying with all company safety policies and procedures. MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor's Degree in Engineering required, mechanical engineering preferred. Master's Degree in Engineering preferred.
  • 8 plus years of related experience required.
  • Medical device or Pharmaceutical experience required.
  • FDA industry experience required.
  • Equipment Automation with CAD software experience preferred.
  • Six Sigma and Lean manufacturing experience preferred. KNOWLEDGE, SKILLS AND ABILITIES
    • Experience in a regulated environment.
    • Demonstrated strong verbal and written communication skills.
    • Demonstrated strong project management skills.
    • Experience in manufacturing process control and process validation requirements, including statistical tools.
    • Strong technical aptitude.
    • Proficient with computer programs, e.g. Ms Excel, Power Point, Project and CAD software.
    • Demonstrated strong root cause analysis and problem solving skills.
    • Excellent collaboration and team building skills.
    • Demonstrated time management and priority setting skills.
      EEO Policy Statement
      Conditions of Employment: Haemonetics's requires COVID-19 vaccination for all U.S. employees who work in the presence of other colleagues or customers, unless the employee is approved for a medical or religious exemption, pursuant to applicable law. While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, customers and communities as we continue to make health and safety our top priority.
      Pay Transparency:
      The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role.
      In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, "flexible time off" for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits.
      Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email AskHR@Haemonetics.com.
      The base salary range for this role is:
      $83,821.00-$113,273.00/Annual

Keywords: Haemonetics, Covina , Principal Manufacturing Engineer, Engineering , Covina, California