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
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