CP is ranked 3rd in the NJBIZ Top 50 Companies to Work for and is listed in NJBIZ 50 Fastest Growing Companies in NJ.

CP Professional Services (CP) is a full service Life Sciences Quality and Compliance consulting firm also offering Full Service Engineering consulting services headquartered in Sparta, New Jersey with offices in Florham Park NJ and San Diego CA. CP is committed to our clients and develops innovative strategies and targeted solutions necessary to exceed standards and our clients' individual needs, goals and expectations.

Works as a Product Technology team member on cross-functional teams throughout the remediation process.  Performs or oversees biomedical/mechanical engineering, design, and development work.  Develops design concepts and ideas for product improvements.  Develops prototypes of design concepts for engineering testing and evaluation.  Generates or reviews/approves SOPs, test protocols, laboratory research reports and provides laboratory oversight as needed. Responsible for adhering to design controls and 

RESPONSIBILITIES

• Conceptual design of product enhancements for on-market pre-hospital emergency care products
• Using existing design inputs as a baseline, develop/ execute planning documents, engineering studies, design verification, and design reports for product enhancements to existing on-market products
• Develop engineering prototypes of design concepts
• Lead or participate in risk analysis activities
• Develop or collaborate on project plans and budgets
• Develop and adhere to strict project timelines
• Generate or review/approve test protocols and reports
• Comply with FDA Regulation and Guidance for Combination Products

Top two skills absolutely required:

1. Must be experienced as a Senior Design Engineer doing remediation of “on-market products”, rather than with new products.
2. Must have Design Engineer experience in a Combination Products environment. Experience must include complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives.

BASIC QUALIFICATIONS

• B.S. Degree in Engineering discipline with 5–7 years’ exp
• M.S. Degree in Engineering discipline with 3–5 years’ exp
• Ph.D. in Engineering discipline with 1–3 years’ exp

           (Biomedical Engineering or Mechanical Engineering preferred)

 PREFERRED QUALIFICATIONS

• Experience with design remediation of on-market products
• Conceptual design skills and experience with a variety of manufacturing methods (e.g. injection molding, machining, etc.)
• Strong project management skills. Proficient in MS Project.
• Strong laboratory skills such as component inspection or failure analysis, mechanical testing, etc.
• Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.
• Familiarity with human factors and usability engineering
• Experience in complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives
• Ability to prioritize multiple responsibilities and to work on multiple projects simultaneously

1. All your information will be kept confidential according to EEO guidelines.
2. Please attach WORD resume in your profile
3. Work is on-site
4. This is a 12+ month contract/consulting assignment - NOT FTE