Career Opportunities
Join our growing team of experts.Looking for a new career opportunity in a growth industry?
Our team of medical device & combination product experts is expanding.
Suttons Creek is “The Device Team for Pharma”. We are the medical device and software development partner to big and small pharmaceutical companies. Our firm is currently undergoing an exciting period of growth in which we are looking to expand our consulting bench and full-time consultant team quickly. Work arrangements are flexible, providing the opportunity to work remotely – relocation generally isn’t required as we have a bi-coastal team. Compensation for our consultants and full-time employees are benchmarked and competitive with current market rates in the pharmaceutical industry.
SENIOR TECHNICAL PROJECT MANAGER
We are actively seeing team members that can serve as technical leads in team engagements with our client base. This candidate will report directly to our Head of Consulting Services and take direction from him/her on client related projects. Desired candidates will have a breadth of exposure defined by the key qualifications listed below. We offer 401k, health care benefits, and a yearly bonus system tied to personal and company performance.
- Organizing and scheduling technical discussions for internal and client teams as a technical subject matter expert on the development of drug delivery systems
- Holding team members accountable for the execution of project deliverables with industry standards, external regulatory requirements and site quality management systems
- Creating and maintening project plans and program budgets associations with SCI statements of work.
- Assisting the Technical Leads to coordination project needs within clients timelines.
- Preparing detailed, concise reports on project status and report out project execution details to the senior leadership team. This includes monitoring fiscal metrics for individual projects.
- Working within the sales process to create project plans and work with the Head of Technical Services to ensure the resource model is appropriate for the statement of work.
- 7+ years as project/program manager or equivalent experience in the development of combination products and/or medical devices.
- Provides project management for multiple programs in both direct or matrix reporting teams, coordinating team members through the execution of program deliverables.
- Technical project management of medical device programs, preferably in the clinical and commercial development of drug delivery systems (combination products)
- Strong understanding of design history file documentation in quality management systems, including
- Design and Development Plans
- User needs
- Requirements
- Risk management
- Verification
- Validation
- Design Transfer
- Understanding of the application of standards and regulatory requirements to the development of medical devices.
- Preferred that candidate has pharmaceutical-related medical device experience on combination products and/or drug delivery systems
- Understanding of DHF elements, and their integration through the medical device development process.
- Understanding of medical device processes:
- Design Controls (21 CFR 820.30)
- ISO 13485
- ISO 14971
- ISO 62366
- ISO 62304
- EU MDR/IVDR
- Strong project management skills and knowledge of current project management tools and concepts.
- Product Development Process
- Highly preferred, Experience with project management with PMP Certificate.
- Experience with one or more Autoinjectors, Pre-filled syringe, or on-body delivery systems is a plus
- BS in Engineering, Biology, Physics or related Scientific discipline
- Preferred: Master’s degree in Engineering, Biology, Physics or related Scientific discipline is desired.
To apply for this job, click here to email us your resume and a cover letter.
SYSTEMS ENGINEER CONSULTANT
We are seeking a systems engineer experienced in the pharmaceutical and combination product space to join our consulting team.
- Work individually and/or within a consulting team to service the specific needs of our clients
- Collaborate with our executive team to assess new client/project opportunities and create SOWs to present for new business opportunities
- Perform client assessments
- Develop and execute client project strategies and trainings
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Experience with design and general program management through all phases of device development
- Familiarity with regulatory guidance documentation such as ISO 13485, ISO 14971, IEC 60601, etc.
- 5-10 years of experience within the pharmaceutical and/or combination product industry
To apply for this job, click here to email us your resume and a cover letter.
PRINCIPAL SYSTEMS ENGINEER CONSULTANT
We are seeking an experienced system engineer in the pharmaceutical and combination product space to join our consulting team.
- Act as Project Lead on assigned client projects
- Work individually and/or within a consulting team to service the specific needs of our clients
- Collaborate with our executive team to assess new client/project opportunities and create SOWs to present for new business opportunities
- Perform client assessments
- Develop and execute client project strategies and trainings
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Extensive experience with design and management of combination product programs through all phases of device development
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Comprehensive experience with regulatory guidance documentation such as ISO 13485, ISO 14971, IEC 60601, etc.
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10-20 years of experience within the pharmaceutical and/or combination product industry
- A proven consulting track record is an advantage
To apply for this job, click here to email us your resume and a cover letter.
QUALITY ENGINEER CONSULTANT
We are seeking a quality engineer experienced within the pharmaceutical and combination product space.
- Work individually and/or within a consulting team to service the specific needs of our clients
- Collaborate with our executive team to assess new client/project opportunities and create SOWs to present for new business opportunities
- Perform client assessments
- Develop and execute client project strategies and trainings
-
Understanding of quality regulations and documents such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Quality System Regulations, ISO standards, etc.
- 5-10+ years of experience within the pharmaceutical and/or combination product industry
To apply for this job, click here to email us your resume and a cover letter.
PRINCIPAL QUALITY SYSTEMS CONSULTANT
We are seeking a consultant with quality systems experience in the pharmaceutical and combination product space to join our team.
- Work individually and/or within a consulting team to service the specific needs of our clients
- Collaborate with our executive team to assess new client/project opportunities and create SOWs to present for new business opportunities
- Perform client assessments
- Develop and execute client project strategies and trainings
- Understanding of quality regulations and documents such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Quality System Regulations, ISO standards, etc.
- 5-15+ years of experience within the pharmaceutical and/or combination product industry
To apply for this job, click here to email us your resume and a cover letter.
REGULATORY AFFAIRS CONSULTANT
We are seeking a regulatory affairs consultant with experience within the pharmaceutical and combination product space to join our team.
- Work individually and/or within a consulting team to service the specific needs of our clients
- Collaborate with our executive team to assess new client/project opportunities and create SOWs to present for new business opportunities
- Perform client assessments
- Develop and execute client project strategies and trainings
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Successfully submitted a product for approval
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Experience interpreting and responding to regulatory body requests for information
- Familiarity with regulatory guidance documentation such as ISO 13485, ISO 14971, IEC 60601, etc.
- 5-15+ years of experience within the pharmaceutical and/or combination product industry
To apply for this job, click here to email us your resume and a cover letter.