• CP Professional Services (CP) is a full service Life Sciences Quality and Compliance consulting firm also offering Engineering 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.

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

Provide technical leadership on cross-functional teams throughout the development process from concept through commercialization.  Develops design concepts and ideas for new products and product improvements.  Oversees biomedical/mechanical engineering, design, and development work on assigned projects including prototyping and testing and evaluation.  Manages CROs and performs human factors (usability studies), market assessment, or clinical research.  Works with Business Development to explore acquisition or partnership opportunities.  Works with Regulatory to develop strategy for product submissions and approvals.  Responsible for adhering to design controls and documenting all product development work in a Design History File.

ROLE RESPONSIBILITIES

• Provide technical leadership to Biomedical Engineers and cross-functional teams within Meridian/Pfizer
• Conceptual design of new drug delivery systems or product enhancements for pre-hospital emergency care products
• Develop design inputs with associated justification for new product development
• Lead risk analysis and risk management activities including human factors studies
• Approve designs, test protocols, and reports
• Justify new product development and develop project plans and budgets
• Conduct business development research and due diligence activities
• Conduct research and publish as appropriate
• Comply with FDA Regulation and Guidance for Combination Products

PREFERRED QUALS

Absolutely must have DESIGN EXPERIENCE IN A COMBINATION PRODUCTS ENVIRONMENT TO BE CONSIDERED.

• Excellent leadership, interpersonal, and organizational skills
• Conceptual and creative design skills
• Human factors and usability engineering experience
• Experience with various manufacturing methods such as injection molding, metal stamping, machining, etc.
• Strong mathematical, analytical, and reasoning skills
• Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.
• 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
• Responds to requests for service and assistance with professionalism, courtesy, and confidence

EDUCATION:

• B.S. Degree in Engineering discipline with 12+ years’ experience
• M.S. Degree in Engineering discipline with 9 years’ experience
• Ph.D. in Engineering discipline with 7 years’ experience

Absolutely must have DESIGN EXPERIENCE IN A COMBINATION PRODUCTS ENVIRONMENT TO BE CONSIDERED.

• Excellent leadership, interpersonal, and organizational skills
• Conceptual and creative design skills
• Human factors and usability engineering experience
• Experience with various manufacturing methods such as injection molding, metal stamping, machining, etc.
• Strong mathematical, analytical, and reasoning skills
• Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.
• 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
• Responds to requests for service and assistance with professionalism, courtesy, and confidence

This is a 12+ month consulting assignment with the possibility of being extended or converting to an FTE with the direct customer.

Must be local to the client site in Columbia, MD or be willing to temporarily relocate there.  

All work is on-site

W2 OR 1099 

All your information will be kept confidential according to EEO guidelines.