To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $35 to $40 per hour. (Negotiable)

Industry: Pharmaceutical

Work Type: Onsite Monday to Friday

Contract Duration: 12 Months (Possibility of Extension)

Job Summary:

• The Product Development Engineer supports the design development testing and scale up of medical devices and drug device delivery systems within a regulated pharmaceutical environment.
• This role focuses on laboratory experimentation product and process development and design verification and validation activities.
• The engineer collaborates closely with quality regulatory manufacturing and supply chain teams to ensure manufacturing readiness.
• The position plays a key role in translating laboratory concepts into robust commercially manufacturable products.
• Strong technical documentation data analysis and presentation skills are essential for success in this role.

Key Responsibilities:

• Support product development activities from laboratory scale through commercial manufacturing.
• Design and execute laboratory studies for medical devices and combination products.
• Conduct design of experiments to evaluate product functionality reliability and manufacturability.
• Perform data analysis summarize results and prepare technical reports and presentations.
• Support design verification and design validation testing activities.
• Develop experimental protocols test methods and investigation plans.
• Participate in risk assessments and creation of test plans based on risk priorities.
• Support technology transfer process development and scale up activities.
• Collaborate with cross functional teams including quality regulatory manufacturing and supply chain.
• Support interactions with contract manufacturing organizations.
• Troubleshoot manufacturing and process challenges and support investigations.
• Prepare and review technical documentation including SOPs batch records and validation protocols.
• Stay current with industry trends and best practices in pharmaceutical and medical device development.

Required Qualifications:

• Bachelors degree in Biomedical Mechanical Chemical Materials Science Pharmaceutical or related Engineering field.
• One to five years of hands on experience in product development for medical devices drug delivery systems or combination products.
• Laboratory experience supporting product development and manufacturing processes.
• Hands on experience with biomedical and mechanical design development and lab testing.
• Experience with drug product stability and chemical reactions in primary containers.
• Product development experience with knowledge of commercial scale manufacturing.
• Strong understanding of medical device or pharmaceutical product development.
• Experience conducting design of experiments product testing and data analysis.
• Excellent technical writing data summarization and presentation skills.

Preferred Qualifications:

• Masters or Doctoral degree in Engineering or related field.
• Experience with electro mechanical pump devices.
• Experience with prefilled syringes cartridges auto injectors eye care devices or pumps.
• Familiarity with FDA ISO standards and design history file documentation.
• Knowledge of cGMP environments and regulatory requirements.
• Experience in human factors usability studies and design controls.
• Formal project management experience.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)