Product Development Engineer

This is an onsite position 100% of the time.

Summary of Contractor Engineer Focus on Medical Devices, Drug Device Delivery Systems and Combination Products

• Experience in developing medical devices, device-drug delivery systems, and/or combination products.
• Broad experience in product and process design, development, design verification and design validation and patient usability applications.
• Product development experience and commercial scale manufacturing knowledge are a must have.
• Strong understanding of pharma or medical device product development and capability of problem solving to unique problems with solutions.
• Hand-on experience with lab study related to biomedical and mechanical design and development, drug product stability and chemical reactions in primary containers.
• Experience in multiple combination products with the focus on electro-mechanical pump devices and primary containers for drug delivery to the patient for disease therapies.
• Excellent technical writing skills, data summary, technical report, slide presentation are required
• FDA and ISO standards, design history file, project management professional (PMP) experience will be helpful.
• Prior experience and knowledge of pre-filled syringe and cartridge, auto injectors, eye care, or eye droppers, aesthetics, and pumps will be helpful.

Job Requirements

• Lab experiences of product development and manufacturing process at medical device, combination products, device-drug delivery.
• Conduct DOE and test the product functionality, manufacturability, reliability with the characterization for accuracy, sensitivity, and selectivity.
• Establish methods for product investigations, including analysis of testing programs for adequacy and sequence, compliance with requirements, and preparation of reports.
• Data analysis, summary and slide deck preparation, presentation of design, develop, and test medical devices and combination products.
• Excellent written skills, outstanding communication and interpersonal skills, and ability to work independently and manage time effectively.

Job Responsibilities:

• Technical support of produce development and leadership at lab study scale up for commercial manufacturing of medical devices, drug device delivery systems, and combination products.
• Cross-function engagement and team matrix working experiences in portfolios of drug delivery system product development projects.
• Advances in scientific and engineering of medical device related experimental DOE design of experimental activities for the engagements with internal teams and external partners.
• Supports the experimental lab execution, data generation and collection, results summary and slide deck preparation and presentation at weekly meeting.
• Interface engagement of the project cross-function team and governance process and forward-looking evaluation of potential risk with timely problem solving.
• Supports in tech transfer, process development, optimization, and scale-up activities. Work closely with contract manufacturing organizations (CMOs) to ensure technical and operational alignment with company standards.
• Plans, designs, executes, documents, and analyzes a regimen of tests to evaluate, verify and/or validate a system.
• Provide knowledge in pharmaceutical manufacturing processes, particularly small molecules and biological drug related device delivery systems and combination products
• Interface with project and laboratory teams to develop DOE and functional tests, experimental protocols, and new target evaluations.
• Assesses risks and creates test plans around risk priorities; analyzes results, states conclusions, and assesses residual risks after tests are complete; in addition, assesses adequacy of support for conclusions by test results.
• Understands regulations, apply guidance and standards on design verification and design validation to test activities and work products; prepares documentation for compliance with standard operating procedures
• Develop and review technical documentation, including standard operating procedures (SOPs), batch records, and validation protocols.
• Troubleshoot manufacturing challenges and support investigations into deviations or process failures.
• Collaborate cross-functionally with marketing, quality, regulatory, and supply chain teams to ensure seamless operations.
• Stay up to date with industry trends and best practices in pharmaceutical product development and lab, pilot and scale up manufacturing and commercial production.

Qualifications

• BS degree as minimum requirements of 1-5 years (MS preferred and PhD acceptable) in the field of biomedical, mechanical, chemical, materials science and engineering, biotechnology and pharmaceutical related engineering fields.
• Experience in developing medical devices, device-drug delivery systems, and/or combination products. Broad experience in product and process design, development, design verification and design validation and patient usability applications.
• Product development experience and commercial scale manufacturing knowledge are a must have. Strong understanding of electromechanical device development and process techniques, including design, development, lab testing, and drug-device interaction and system testing.
• Familiarity with cGMP, regulatory requirements (FDA, EMA), and quality assurance practices in medical device, drug-device systems and combination products biomanufacturing.
• Hands-on experience working with contract manufacturing organizations (CMOs) requirements is a plus.
• Excellent problem-solving skills and ability to work in a fast-paced environment.
• Strong communication and collaboration skills to effectively engage with internal and external stakeholders.
• Excellent problem-solving skills and ability to work in a fast-paced environment. Strong communication and collaboration skills to effectively engage with internal and external stakeholders.
• Prior experience in technology transfer and process validation preferred. Prior knowledge of analytical methods and process development and characterization preferred.
• Broad knowledge in design controls, human factors studies, design verification/validation and usability studies.

Education:

• BS degree as minimum requirements of 1-5 years
• MS preferred 0-3 yrs
• PhD acceptable in 0-3 yrs

What are the top 3-5 skills, experience or education required for this position:
1. Lab experiences of product development and manufacturing process at medical device, combination products, device-drug delivery.
2. Conduct DOE and test the product functionality, manufacturability, reliability with the characterization for accuracy, sensitivity, and selectivity.
3. Establish methods for product investigations, including analysis of testing programs for adequacy and sequence, compliance with requirements, and preparation of reports.
4. Data analysis, summary and slide deck preparation, presentation of design, develop, and test medical devices and combination products.
5. Outstanding communication and interpersonal skills and Ability to work independently and manage time effectively.

The benefits that you are eligible for with Collins Consulting, Inc:

• 401(k)
• Medical, Dental and Vision Insurance
• Term Life Insurance
• Accidental Death and Dismemberment
• Long Term Disability