Join Our Client to turn science into innovative drug delivery systems! Requires an Engineering BS with 6+ yrs in device/combination product development (3+ in delivery systems). Help create life-changing technologies!
location: Cambridge, Massachusetts
job type: Contract
salary: $110 - 130 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Lead combination product design & documentation by developing and maintaining Design History Files (DHF), design inputs/outputs, V&V strategies, and traceability matrices.
- Drive risk management & technical problem-solving by conducting root cause analyses, evaluating vendor complaints, and resolving complex design and process issues.
- Manage lifecycle & Device Master Records (DMR) for drug delivery systems, overseeing design changes, impact assessments, and reverification/revalidation plans.
- Oversee external partners & contract laboratories to guide verification testing, analyze technical data, and align constituent part development with project milestones.
- Evaluate emerging delivery technologies by leading feasibility studies, prototyping innovative concepts, and supporting pipeline drug delivery strategy.
qualifications:
Bachelor's degree in biomedical, electrical, mechanical, or a related engineering discipline.
Minimum of 6 years of experience in device and/or combination product development.
At least 3 years of specialized experience with drug delivery systems such as autoinjectors, pre-filled syringes, wearable injectors, pen injectors, or drug reconstitution devices.
skills:
AI-enabled,CodeBeamer,DOORS,user interactions,JAMA,Polarion,software tool,test data,verification and validation,communicating,enthusiasm,problem-solving,drug delivery,assembly,biomedical,change control,Clinical,commercialization,authoring,prototypes,prototyping,Device Development,Design for Manufacturing,modeling methodologies,Design for Six Sigma,Design of Experiments,electromechanical,Human Factors,trade show,impact assessments,ISO 13485,ISO 14971,injectors,innovative,innovation,infusion,Packaging,labeling,landscaping,lifecycle management,Manufacturing,manufacturing companies,mechanical engineering,medical devices,handheld,modeling,new product development,product Design,product development,new product introduction,project planning,Regulatory Affairs,compliance requirements,regulatory filings,investigations,research and development,risk assessments,risk,risk analyses,risk management,performing root cause analysis,internal and external stakeholders,streamline,sustaining engineering,engineering analysis,technical documentation,technical reports,technical investigations,Lead technical,test methods,testing,21 CFR,traceability,workflows
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
