Sr. Design Engineer

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Monroe, OH
3-5 Years Experience
Pharmaceutical
The Role

CSafe is seeking a in Monroe, Ohio to join our world class global engineering team! In this role, you will lead in the designing, developing and qualifying temperature-controlled shipping solutions used for the transportation of medical or pharmaceutical products. Additionally, you will provide designing support to the engineering team in the form of product R&D, designing, development, testing, analysis, documentation and related skills for project management for CSafe's products. Come join our growing industry and build your career with us!

CSafe offers the most comprehensive temperature-management solutions for pharmaceutical cold chain shipping needs around the world to ensure patients receive life enhancing products. With a "patient-centered" focus, deep industry expertise and commitment to innovation, CSafe continues to deliver industry-leading solutions across multiple business segments. Our team operates with curiosity, humility, accountability, and entrepreneurial spirit to deliver on our vision and mission.

  • Lead the design and development of innovative solutions from concept to production release, in collaboration with cross functional teams.
  • Utilize technical expertise and creativity to solve complex engineering challenges and optimize product performance.
  • Collaborate with major stakeholders to define product requirements, objectives, and deliverables, ensuring alignment with company goals
  • Provide guidance on design to ensure product and sub systems are Designed for Manufacturability, Assembly and Disassembly (DFMAD).
  • Develop necessary 3D models, 2D drawings, & indented bills of materials required to complete designs per engineer's instructions from sketches, notes, or verbal instructions.
  • Ability to support Thermal Modeling & Lane Risk analysis studies using industry simulation software.
  • Maintain properly archived data and follow procedures, protocols & conventions associated with Product Data Management (PDM) and Product Life Management (PLM).
  • Write environmental and physical test protocols/plans, configure products, perform testing, analysis the results and compile validation documentation.
  • Ability to make engineering calculations for weights, center of gravity, load restraint and geometrics.
  • Ability to lead and formulate FMEA studies for complex systems in accordance with standard industry practices, preferably within the field of aviation safety and medical devices.
  • Support internal/external activities associated with design, manufacturing and supplier chain to ensure products conform to our required high standards of quality and performance.
  • Provide product expertise and ownership to assigned products. May support products through design and development, testing, manufacturing, customer/field, and improvement (cost/warranty/reliability) efforts.

  • Bachelor's degree in engineering, Mechanical or Aerospace preferred.
  • 7 Plus years' experience in product design and development role of complex system and integration within a mobile unit would be advantageous.
  • Product development and project management experience in a fast-paced environment.
  • Experienced designer of mobile battery-operated systems for use in harsh environments.
  • Design and product knowledge of refrigeration and controls systems would be advantageous.
  • Experienced user of 3D modeling/2D CAD software (Solidworks) and design simulation software.
  • Ability to draft supporting documentation such as test protocols, test reports, work instruction and product/user guides.
  • Excellent problem-solving skills with the ability to analyze complex issues and develop effective solutions.
  • Aptitude for understanding product features, functions and failure modes at a technical level.
  • Should be proficient in using a variety of hand tools for the development and adjustment of parts and assemblies during the prototyping process.
  • High attention to detail, accuracy and excellent workmanship.
  • Familiarity with industry regulations, standards, and compliance requirements
  • Ability to follow processes and procedures to ensure integrity of product design.
  • Knowledge of Product Data Management (PDM) and Product Life Management (PLM) would be beneficial.
  • Knowledge of Microsoft 365 suite of programs. Must be proficient user of Microsoft Word & Excel.
  • Ability to define, create, read and understand technical drawings and bills of materials (BOM) relative to industry standards.
  • A willingness to quickly adjust priorities based on business needs.
  • Strong interpersonal skills, both written and verbal, are important.
  • Organizational skills; able to meet deadlines.
  • Must possess analytical thinking and reasoning skills.
  • Must be self-motivated and be able to self-manage.
  • Must be thorough and exercise attention to detail.
  • Must be a team player.

  • Paid Time OFF (PTO) starting at 25 days & Paid Holidays
  • Medical, Dental and Vision Insurance
  • 401k with Employer Match
  • Group Life & Disability
  • Health Spending Account Options
  • Identity Protection
  • Employee Assistance Program
  • Travel Assistance Program
  • Financial Wellness Program
  • Tuition Reimbursement
  • Parental Leave
  • Referral Program
  • Gym Membership Reimbursement
  • Hybrid Work Options

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

The Company
HQ: Monroe, OH
174 Employees
On-site Workplace
Year Founded: 1979

What We Do

CSafe manufactures and offers a full range of active, passive and cell & gene cold chain packaging solutions designed to thermally protect pharmaceutical and life-science products as they ship to patients across the globe.

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