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Sr. R&D Engineer - Fremont, United States - Aulea Medical Inc.
Description
From the CEO: If you see yourself as a crafty engineer like MacGyvver and want to grow rapidly along with your team, we will welcome you into our family.
Position Summary: Responsible for providing engineering support in the creation and the development of the product.Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Authorities: Has the authority to identify and record problems relating to product and component design and to recommend or provide solutions to interface with vendors, order parts, fixture for R&D purposes
Duties & Responsibilities:
Design and develop product(s) in full compliance with the companys Design Control requirements and consistent with FDA QS Regulations, ISO 13485, MDD 2007/47/EC, and Canadian Medical Devices Regulations.
Responsible for ensuring proper documentation consistent with companys quality system.
Responsible for knowing and planning activities consistent the companys quality policy and quality objectives.
Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP.
Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
Research, develop, design, and evaluate mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
Develop new concepts from initial design to market release.
Maintain detailed documentation throughout all phases of research and development.
Design and analyze device sub-systems and components.
Responsible for technical documentation.
Conduct feasibility studies to verify capability and functionality.
Direct support personnel and coordinate project activities.
Investigate and evaluate existing technologies.
Reviews or coordinates vendor activities to support development.
Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to companys products.
Provide support in the resolution of product complaints and/or safety issues.
Position Requirements:
Technical Expertise
Extensive mechanical and electro-mechanical development experience
Able to develop layouts incorporating concepts in engineered installation drawings and sketches.
Able to prepare layouts for a complete device characterized by critical mechanical dimensions.
High level of competence in 3D modeling and generate complex 3D models and drawings of mechanical systems in order to meet quality and content requirements under the guidance of engineering management.
Extensive range of medical device experience
Extensive experience with system functionality and reliability verification
Wide application of technical principles, practices, and procedures.
Good technical skills and proven engineering problem solving ability.
Design Control Expertise
Medical device industry experience: 510(k) experience highly preferred - PMA products helpful.
Advanced understanding of disciplined product development processes, regulatory and quality requirements, and the use of CAD design, simulation tools, and Design Of Experiments (DOE).
Must be able to conduct technical review and generate design documents such as requirement specification, design specification, failure mode effect analysis, etc.
Experience in creating test protocols, reports, manufacturing procedures, inspection procedures, etc.
Familiarity with medical device design control processes
Some GMP familiarity 21 CFR part 820, ISO 13485:2003, medical industry experience
General Expertise
Excellent written and oral communication skills with ability to solicit cooperation and support of individuals across departmental boundaries.
Proficient in MS Office, MS Project and Solidworks
Experienced in a fast paced product development atmosphere.
Strong understanding of business unit functions and cross group dependencies/relationships.
Must possess good interpersonal and communication skills, and work in a collaborative style.
Education:
Bachelors Degree in Mechanical or Biomedical engineering.Advanced degree preferred.
Experience:
Minimum 5 years of experience in engineering preferably in the medical device and/or pharmaceutical industry with successful track record of delivering products to market or developing commercially viable technology.
Preferred Requirements:
Technical Expertise
Experience in development of disposable device is very helpful
Experience in RF technology is very helpful
Experienced in the performance of Tolerance Stack-Up analysis, PLUS - Mold Flow and Stress Analysis among many engineering skills.
Thorough knowledge of ANSI Drafting standards and GD&T
General Expertise
Experience as a technical team leader is very helpful
Ability to travel domestically and internationally if required.
Effective management of schedule, expenditure, product quality, product cost and development risk trade-offs
