R&D and Process Engineer

Company Description

AgNovos is a biotechnology company that develops new treatments leveraging regenerative medicine to address persistent unmet medical needs related to bone disease. The Company was founded by Dr. James Howe, a renowned orthopedic surgeon who worked in clinical practice and research for more than thirty years.  The first therapeutic area that we are addressing is osteoporosis, a condition afflicting millions of people, especially women. The disease is characterized by lost bone volume and quality, reduced bone strength and increased fracture risk. In response to what many experts consider an osteoporosis crisis, AgNovos is working to transform the landscape of bone health.

Job Description

Summary of Position:

AgNovos is seeking an engineer for our R&D group. The position will focus on supporting the development and manufacturing processes of AgNovos’s lead products.  This position will have a broad range of responsibilities including design verification/validation testing, designing and executing laboratory experiments, cleanroom activities, and protocol and report writing.  The successful candidate will have notable attention to teamwork, detail, passion for learning, organizational skills, time management, and communication skills. 

This position is 100% on-site (in the office), with minimal travel requirements (1/year).

Applications should include GPA for consideration.

Essential Duties and Responsibilities:

• Conduct and monitor project testing and experiments to provide data, results analysis, and reports to stakeholders inside and outside the R&D team.
• Exercise technical judgement in the design, execution, and reporting of experiments including development studies and design verification/validation activities. 
• Support manufacturing and production activities, including executing production activities that align to production schedules issued for manufacturing operations.
• Contribute to, author and manage design history file documents such as design inputs, risk management and test reports.
• Develop and prepare test protocols, reports and engineering summaries with expertise in technical writing capabilities.
• Perform literature reviews.
• Ensuring that all design activities adhere to internal procedures, FDA Quality System Regulations and ISO 13485 design control and risk management requirements.
• Support material/design/process changes through design control process, with well-documented research/analyses.
• Maintain a laboratory notebook and other technical documentation according to required guidelines.
• As requested, provide product or project support to other teams.
• Work both independently and in small groups within a laboratory, manufacturing, and office environment.

Qualifications

• BS in engineering (e.g. biomedical, chemical, mechanical) or chemistry/biology.
• Up to two years’ experience in a product development or regulated laboratory environment including GMP/GLP.
• Excellent written and oral communication skills.
• Experience with CAD programs such as SolidWorks a plus
• Preferred to have prior laboratory experience in, or knowledge of, biomechanical testing and biomaterial characterization.
• Preferred to have experience with statistics such as sample size determination and power analysis.
• Must be self-motivated, self-starter capable of learning quickly and working independently with minimal direct supervision. 
• Capable of following instructions and procedures with a focus on accuracy, consistency, and precision.
• Must be flexible and willing to learn new skills.
• Able to work individually and collaboratively with a variety of individuals.
• Able to work on multiple projects simultaneously and appropriately prioritize efforts.
• Good written and oral communication skills.
• Time management and project management skills.

Additional Information

Physical Requirements:

• Routine required bending, stooping, twisting, sitting, standing, and walking.
• The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• Office-based environment.
• While performing the duties of this job, the employee may need to wear Personal Protective Equipment (PPE) such as goggles, face shield, surgical mask, bouffant cap, gloves, etc. The employee may be exposed to biohazards.
• Lab-based, manufacturing and office-based environments.

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

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

Compensation & Benefits:

The salary range for this position is $60k-$75k annually.  Final salary will be determined based on several factors including market analysis, experience and internal equity.

AgNovos Bioscience offers a comprehensive suite of benefits including medical, dental, and vision coverage to a 401(k) plan with company match.  This position is on-site in the Rockville, MD office 5 days per week.