Sr Mechanical Design Engineer - Hialeah, United States - Artech
Description
Job Title:
Sr Mechanical Design Engineer
Job ID:13413
Location:14400 NW 60th Ave Miami Lakes Florida 33014
Duration: 06 Months Contract
Must Have
10+ years of product development with 4+ years product development of medical devices, class III preferred.
Advanced understanding and application of GD&T (Geometric Dimensioning and Tolerancing).
Advanced understanding of design controls, quality system regulations, and failure investigation process and methodologies.
BS degree in Mechanical Engineering or MS preferred in Mechanical or Biomedical Engineering
Excellent verbal and written communication
Must have demonstrated completion of development projects to commercialization
PC application skills:
solid modeling (SolidWorks), MS Project, EXCEL, Word, Minitab, Agile PLM
JOB DESCRIPTION
I'm looking for a well-experienced Mechanical Design Engineer, with knowledge of electronics packaging for external battery-powered implantable devices using microprocessor control.
Should have experience with micro-processor controller enclosures, external batteries enclosures, AC & DC Adapters and Cables for powering peripheral devices.
Experience working with electronic devices Contract Manufacturers is necessary. Experience with FDA 21 CFR 820 Design Controls is necessary.Education Required
" BS degree in Mechanical Engineering or MS preferred in Mechanical or Biomedical Engineering
Years of Experience
" 10+ years of product development with 4+ years product development of medical devices, class III preferred.
" Must have demonstrated completion of development projects to commercialization
Specialized Knowledge or Skills Required
" Ability to meet program deliverables and timing, and thrive in fast-paced environment.
" High organizational and multitasking abilities.
" Excellent verbal and written communication.
" Advanced understanding of design controls, quality system regulations, and failure investigation process and methodologies.
" PC application skills:
solid modeling (SolidWorks), MS Project, EXCEL, Word, Minitab, Agile PLM
" Advanced understanding and application of GD&T (Geometric Dimensioning and Tolerancing).
" Understanding of international medical device standards.
" Understanding of Risk Management Process.
" Advanced understanding of Design-for-Manufacturability (DFM) and Design-for-Assembly (DFA)
" Experience with test methods validations and statistics.
Designs components or portions of systems and modifies existing designs to develop or improve products and facilitate manufacturing and field service operations.
" Assist in the design and development, and perform sustaining engineering, of various mechanical and electromechanical components used in Client MCS products.
" Assist with bench testing of assemblies and parts to ensure performance
" Maintain top level engineering documentation.
" Perform Design Verification and Validation testing
" Write Test Protocols & Test Reports
Utilizes computer-aided design equipment and/or graphic tools, such as CAD, CAM, CATIA, ProEngineer/Creo, Solidworks or Siemens NX Software.
SolidWorks SME proficiency required.
Gathers information, makes studies, computes calculations, and prepares original rough layouts, sketches to present design proposal.
Coordinates design criteria with manufacturing, tooling, material, and planning groups such as ease of manufacture, availability of materials, and contractual specifications.
40 hours/week
Does this position require the candidate to be onsite or remote?
Position requires hybrid onsite/remote work; onsite 3 days per week (Tuesday - Thursday), remote 2 days per week (Monday & Friday).
Onsite presence may be necessary for up to 5 days per week depending on type of work being performed, such as product testing.
Responsibilities may include the following and other duties may be assigned.Researches, plans, designs, verifies, validates and develops mechanical and/or electromechanical products and systems, such as metals, instruments, controls, plastics, robots, engines, machines and mechanical, resonance, hydraulic or heat transfer systems for production, transmission, measurement, and use of energy.
Recommends various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs.
May be responsible for the transfer from R&D to manufacturing.SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals.
The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
DIFFERENTIATING FACTORS
Autonomy:
Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact:
May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity:
Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
Communication and Influence:
Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
Leadership and Talent Management:
May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .
Required Knowledge and Experience:
Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management.
Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Ritu LalvaniTechnical Recruiter
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