Research and Development

Distribution/Safety

Job Summary:

Responsible for designing and developing products that incorporate Cerapedics peptide technology platform.  This development activity should be done in consort with input from various stakeholders, including the commercial team, operations, and quality.  In addition to product development activities the candidate will need to develop new manufacturing methods and quality control test protocols and/or modify existing test methods to ensure that the new products can be manufactured and packaged in a manner consistent with industry norms.

Specific Functions and Responsibilities:

  • The candidate should be able to work independently, planning a reasonable course of action that incorporates published information and practices into the development program.
  • The candidate must be capable of documenting their work sufficiently well so that the research and development activities can be preserved, understood by others and used in support of any patent activities that might arise from the work.
  • The candidate must be able to communicate verbally sufficiently well to be able to interact with   other team members and outside contract research organizations.
  • Coordinates studies with outside organizations.
  • Follows procedure to ensure compliance with Design Control Procedures.
  • Complies with Cerapedics procedures and directives, FDA and ISO requirements.
  • Responsible for Design Control documents, DHF.
  • Writes validations as needed.
  • Responsible for taking a timely and proactive participation in FDA and Cerapedics required training as outlined in the Personnel Training Procedure.
  • Responsible for additional tasks/duties as required or requested by supervisor.

The above description outlines the most common job duties; however, it does not exclude other potential work assignments.


Education or Formal Training Required

  • 4-year degree in Chemical or Biomedical Engineering
  • Masters degree desirable

Qualifications Required: (knowledge, skills, abilities, initiative, judgment, etc.)

  • 3 or more years experience in medical device product development & design control
  • Experience with resorbable biomaterials
  • Experience with bone graft materials a plus
  • Solid problem-solving skills
  • Solid analytical knowledge of biomaterials
  • Strong decision-making skills
  • Excellent communication skills – both written and oral
  • Strong multi-tasking ability
  • Ability to work as a team player – proven ability to interact with manufacturing, marketing & quality departments
  • Ability to follow written guidelines
  • Ability to write and interpret specific protocols
  • Mathematical ability
  • Ability to work independently, plan and prioritize
  • Ability to be flexible/adapt as daily schedule may change rapidly
  • Computer proficiency

Work Conditions / Physical Demands:

  • The physical demands described here are representative of those that must be met by an employee to successfully preform the essential functions of the job. Reasonable accommodations may be made when requested by the employee to enable individuals with disabilities to perform the essential functions.
  • This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely.
  • This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs.
  • This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination.
  • Minimal supervision. A wide degree of latitude is expected. Relies on experience and judgment to plan and accomplish goals.

Travel requirement: <10%

Benefits/Compensation (including but not limited to):

Medical and dental insurance, group life insurance, 401k matching, long term disability, potential target bonus, paid time off.

Salary Range: 80-100k

We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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