Mechanical Engineer

at Apex Systems
Location Carlsbad
Date Posted April 28, 2021
Category Trades & Services
Engineering
Job Type Not Specified
Full Time

Description

Hours per Day

8

Hours per Week

40

Contract-to-hire depending on candidate performance

On site in Carlsbad

Pay: $50-51 an hour

Senior Mechanical Engineer focused on gas sensing, capnography & related accessory products. As the senior mechanical designer, you will be responsible for the mechanical design of various gas sensing products; next generation and on-market.
You will utilize the following knowledge and expertise to create market-leading products: optical sensing techniques, absorption spectroscopy, high-precision miniature optics, understanding of gas sensing devices, host system implementations, medical device design and development, and regulatory landscape.
The position within the Gas Sensing Technology R&D group collaborates closely with other R&D functions (electrical, optics, software, systems), Marketing, Clinical Affairs, and Quality & Regulatory. This position may require domestic or international travels up to 10% of the time.

Competencies:

• Technical expertise:
o Design: compact, miniature, light-weight opto-mechanical architectures.
o Design: de-sensitize optical designs to environmental influences (e.g. thermal, vibration, atmospheric).
o EDA Tools: SolidWorks, FEA, Zemax.
o Reliability: de-rating analysis, Six Sigma (DFSS), failure analysis, physics-of-failure.
o Regulations: IEC 60601-1, IEC 60601-1-2, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR, etc.
o Solid Mechanical Engineering fundamentals and problem solving skills up through system-level.

• Documentation:
o Schematics, architecture documents, requirements documents, technical reports.
o Characterization procedures, test procedures, and test fixtures.
o Verification & validation plans, protocols, and reports.
o Project plans, project schedules, risk / benefit / cost analysis.

• Process:
o Design control, quality system, risk management, dFMEA, PDP, CAPA.
o Mechanical design process from concept to architecture to volume production.
o Prototype bring-up and debug, bug tracking, functional verification, performance characterization.
o System development process - concept, schematics, system bring up and debug.

• Work habits:
o Strong communication and presentation skills.
o Communicate ideas and issues effectively to other team members and management.
o Participate in project teams in NPI, failure investigations, sustaining engineering, etc.
o Strong multidisciplinary collaboration experience - EE, Optics, SW, ME, SE, QA, RA, Marketing, Clinical, etc.
o Experience with team collaboration and project management tools.
o Work in a matrixed environment to meet company objectives.
o Actively learn to become the domain expert on our gas sensing devices.

Essential Functions:
• Participate in project teams in NPI, failure investigations, sustaining engineering, etc.
• Communicate ideas and issues effectively to other team members and management.
• Create and document designs (e.g. schematics, drawings, test results, data analyses, PCB design etc.).
• Build prototypes for feasibility, functionality, and performance assessments.
• Prepare design documents, requirements documents, architecture documents, technical reports, presentations, as required.

• Contribute to dFMEA, DFT, DFM, risk management, verification & validation plans and reports, etc.
• Collaborate with cross-functional teams regarding standards compliance and global regulatory requirements (e.g. IEC 60601-1, IEC 60601-1-2, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR).
• Assists engineering team in problem solving issues.
• Mentor less experienced engineers.
• Additional responsibilities may be assigned, as required, by management.

Education and Experience:
• Bachelor's or Master's Degree in Mechanical Engineering.
• 5 - 10 yrs of experience in medical device (capital equipment) or related fields (regulated industry preferred).
• Technical lead on mechanical engineering programs.
• Strong working knowledge of hardware (mechanical, optical, electrical) and software / firmware.
• Experience in designing to comply with EMC and ESD requirements.

• High reliability designs, DFT, DFM, (medical devices preferred).
• Compact, miniature, high-density designs, (medical devices preferred).
• Knowledge of ASME Y14.5 Dimensioning and Tolerancing.
• Design verification test development, execution, report generation.
• In-depth knowledge of product development process and design control from concept to volume production.

• In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance.
• In-depth knowledge of medical device regulations and standards (e.g. IEC 60601-1, EU-MDR, FDA cGMP).
• Understanding of capnography or gas sensing products, applications, and technologies a plus.
• Six Sigma (DFSS) Green Belt certification with actual project experience a plus.
• Solid OEM / ODM / CM experience.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice