Manufacturing Process Engineer III
Company: BioSpace, Inc.
Posted on: March 19, 2023
Overview: Responsible for supporting the manufacturing production
line and optimizing manufacturing processes, from engineering
change control through the production and shipment of product. This
includes review of BOM's and accurate translation into SAP.
Essential Duties and Responsibilities:
- Review ECO's to ensure correctness of the BOM's and transfer
the information from Arena (our document control system) into
- Check, validate, and enter the Item Master to ensure
- Work with Production and Materials groups to address BOM
issues, in order to facilitate accurate and efficient back-flushing
and inventory management.
- Help to manage ECO's for operations implementations into the
- Design and facilitate proper materials management on the
- Perform time studies, when needed, to assess line capacity and
to identify areas to improve.
- Create and maintain a model of the production line to determine
capacity and proactively initiate purchase requests for additional
equipment, furniture, tooling, and fixtures that will be needed for
- Create layouts and execute plans to expand the production line,
and to add new products in a manner that optimizes floor
- Improve production line efficiency, flexibility, and work
environment to improve yield, capacity, and product quality.
- Lead projects to introduce new products to the production line
and to improve existing tooling, fixtures, and procedures.
- Document and update work instructions, as needed to maintain
and improve the production line.
- Track and report production yields, improving them to meet
- Perform investigations into line failures, NCMRs, and line
issues, and document findings accordingly.
- Assist in the processing of NCMRs, when needed.
- Perform engineering work typically including one or more of the
- Process/product improvements.
- Process development including IQ/OQ/PQ.
- Process improvements including Validation & Verification.
- Product design for manufacturability, testability and
- Production line layout & facility requirements.
- Report preparation.
- Provide training for line personnel, particularly on new
processes and process improvements.
- Lead and/or participate on project teams to design, develop,
and continuously improve product, equipment, fixtures, and/or
- Perform failure analysis on failed units from field
- Work with Quality to resolve part quality issues from
- Reduce costs through manufacturing process improvement or
- Establish production tooling stock supply chain to make sure
there is no shortage on tooling materials. Qualifications:
- Bachelors degree in electrical, mechanical, or industrial
engineering, or equivalent technical degree, plus 6 years of
relevant experience in a manufacturing environment is
- Experience using SAP or other enterprise system to set up BOM's
and parts management in support of a manufacturing line is
- Arena (or equivalent change management system) experience is
- Experience in an FDA regulated manufacturing environment and
proficiency with medical device development life cycles is
- Ability to focus on and achieve scheduled milestones, including
contingency planning is required.
- Knowledge and understanding of FDA regulations (21CFR 820),
ISO13485, and ISO standards related to medical device manufacturing
- Strong team-working and communication skills. A drive to get
the job done in the face of obstacles and time constraints, and a
willingness to jump in wherever needed.
- Ability to use MS Excel to perform calculations, charting, and
- Competent using office software including MS Word, Excel,
Internet Explorer, PowerPoint, and Outlook. Pro-E competency is
- Individual must have excellent verbal and written communication
skills and a demonstrated ability to communicate clearly and
- Ability to apply concepts such as fractions, percentages,
ratios, and proportions to practical situations.
- Ability to read, understand and abide by company procedures.
Ability to define problems, collect data, establish facts, draw
valid conclusions and report on findings. Additional Requirements:
- Responsible for performing all duties in compliance with FDA's
Quality System Regulation (QSR), ISO13485, the Canadian Medical
Device Regulations, and all other international regulatory
requirements with which ZELTIQ complies. Physical Requirements:
The physical demands and work environment described here are
representative of those an employee encounters while performing the
essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
While performing the duties of this job, the employee is regularly
required to sit, stand, walk, talk and hear; up to 8 hours per day.
The employee is regularly required to lift and carry up to 10
pounds and occasionally lift and carry up to 25 pounds. Duties also
involve daily keyboard data entry. Specific vision abilities
required by this job include close vision.
Applicable to California Applicants Only
- The below range is the range that we in good faith believe is
the range of possible compensation for this role at the time of
this posting. We may ultimately pay more or less than the posted
range and this range is only applicable for jobs to be performed in
California. This range may be modified in the future.
- The salary range is (minimum: _$74,500 to
- This job is eligible to participate in our short-term incentive
- This job is eligible to participate in our long-term incentive
- We offer comprehensive package of benefits including paid time
off (vacation, holidays, sick), medical/dental/vision insurance and
401(k) to eligible employees.
- Note: No amount of pay is considered to be wages or
compensation until such amount is earned, vested, and determinable.
The amount and availability of any bonus, commission, incentive,
benefits, or any other form of compensation and benefits that are
allocable to a particular employee remains in the Company's sole
discretion unless and until paid and may be modified at the
Company's sole discretion, consistent with the law.
AbbVie is an equal opportunity employer including disability/vets.
It is AbbVie's policy to employ qualified persons of the greatest
ability without discrimination against any employee or applicant
for employment because of race, color, religion, national origin,
age, sex (including pregnancy), physical or mental disability,
medical condition, genetic information, gender identity or
expression, sexual orientation, marital status, status as a
disabled veteran, recently separated veteran, Armed Forces service
medal veteran or active duty wartime or campaign badge veteran or a
person's relationship or association with a protected veteran,
including spouses and other family members, or any other protected
group status. We will take affirmative action to employ and advance
in employment qualified minorities, women, individuals with a
disability, disabled veterans, recently separated veterans, Armed
Forces service medal veterans or active-duty wartime or campaign
badge veterans. The Affirmative Action Plan is available for
viewing in the Human Resources office during regular business
Keywords: BioSpace, Inc., Dublin , Manufacturing Process Engineer III, Engineering , Dublin, California
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