SUMMARY: Working independently, coordinates engineering activities for manufacturing transfer of new products, develops in-house processes, supports new and existing products, and provides project management guidance to contract manufacturers. Identifies product design improvement and cost reduction opportunities and executes on proposed changes.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
· Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality or products or services provided to our customers.
· Participate or lead cross-functional teams during product development to ensure design for manufacturability, process development, manufacturing documentation, and pilot operations.
· Select, develop, and validate manufacturing processes, equipment, and tooling.
· Support production through efficient and effective identification and resolution of line issues.
· Identify, initiate, and execute process, cost reduction and product improvement projects.
· Properly document activities in accordance with best engineering practices, company procedures and regulatory requirements. Follow good project management practices.
· Interface with external vendors to source parts, equipment and fixtures.
· Interface with external vendors to resolve supplier quality and process capability issues.
· Within Product Life Management (PLM) (Agile) environment:
· Initiate engineering change requests (ECR) and complete engineering change orders (ECO)
· Structure Bills of Material (BOM)
· Initiate and / or complete non-conformance reports (NCR)
· Initiate and / or complete supplier non-conformance reports (SNCR)
· Investigate and complete corrective and preventive action (CAPA) assignments
· Effectively train operators, technicians, and engineers on use of equipment and fixtures.
· Participate and drive continuous improvement projects related to manufacturing.
· Participate in product development and provide input from a manufacturing perspective.
· Design, develop, and verify product design changes using computer aided design (CAD) software following design control procedures.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND/OR EXPERIENCE:
· Bachelor's Degree (BS) in Engineering discipline with strong hardware (mechanical / electrical) component focus.
· 5-7 years of experience in manufacturing related industry.
· Manufacturing experience in a medical device company a plus.
NECESSARY CERTIFICATES, LICENSES AND REGISTRATIONS
- Good understanding of Lean principles and methodology
- Six Sigma certification a plus
- CAD skills (eCADand mCAD)
- Schematic capture skill a plus.
- Good understanding and usability skills related to Six Sigma
- Design for Reliability (DFR) andDesign for Manufacturating (DFM) and design for Testing (DFt)
- Manufacturing related automation experience a plus
- Microsoft Office Suite.
- Microsoft Project.
- PLM and Product Data Management (PDM)
OTHER SKILLS AND ABILITIES
Familiarity with Food and Drug Administration (FDA)
Guidances and Good Manufacturing Practices (GMP's)
Applicable ISO standards (ISO 13485, ISO 14971, etc.)
· Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
- Must have excellent communication skills (verbal and written).
- Ability to read, analyze and interpret scientific and technical articles and journals.
- Ability to write technical documents to clearly communicate technical requirements, investigative data, and design information.
- Ability to effectively present information to management and/or project development teams.
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations.
- Knowledge and application of basic statistics.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
- Must have logical thought processes and be good at general problem solving.
- Must be a creative thinker.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is regularly required to work at a keyboard and computer.
The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
WORK ENVIRONMENT: The work environment characteristics 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 essential functions.
The noise level in the work environment is moderate.
Location: Seattle, WA
Natus Medical Incorporated is an EOE, M/F/D/V
You may also fax your resume to (206) 268-5104 Attn: Human Resources, referring to the Job Title.
No calls please, principals only and only local candidates will be considered
Natus is a leading provider of healthcare products used for the screening, detection, treatment, monitoring and tracking of common medical...