Senior Design Assurance Engineer (Contract)

Twin Cities Metro, MN | 6-Month Contract
Hybrid – 3 days onsite

We’re looking for a Senior Design Assurance Engineer to support combination drug/device new product development (TDP phase) and integration activities. This role is ideal for someone who thrives in cross-functional environments and enjoys building compliant, risk-based solutions that drive safe and effective products to market.

What You’ll Do

• Lead design assurance activities for new product development projects

• Create and maintain risk management documentation (dFMEA, pFMEA, hazard analysis, risk reports)

• Support GLP studies with protocol oversight and documentation

• Partner with R&D, Regulatory, and Operations on combination product development and design transfer

• Contribute to regulatory submissions through DHF documentation, validation reports, and technical content

What We’re Looking For

• Bachelor’s degree in Engineering, Life Sciences, or related field

• 5+ years in Design Assurance/Quality Engineering within medical devices or combination products

• Hands-on experience with risk documents, GLP studies, and combination drug/device development

• Strong knowledge of FDA 21 CFR Part 4, Part 11, Part 820, ISO 13485, ISO 14971

• Excellent communicator with proven cross-functional collaboration skills

• Bonus: Experience with Windchill and MasterControl

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Opportunity to join and lead the innovative diagnostics department of one of the world's leading manufacturers and contributors to treating diseases in the oncology space. Heavily funded, this division looks to gain regulatory approval for some of the most advanced diagnostic products currently in development, and are looking for a leader dedicated to patient care to lead the strategy and submissions for this talented division.

Primary Responsibilities

• Direct all activities relating to US FDA and analogous international regulatory compliance, such as clinical research and pre-clearance testing for new diagnostic and CDx submissions.
• Implement company wide CDx and Precision Medicine regulatory strategy and define the processes based off previous experiences.
• Develop and implement effective strategies for obtaining necessary regulatory approvals to bring products to market with optimum cost effectiveness and compliance.

Experience Required:

• Minimum B.A/B.S. degree, preferably in an engineering or life sciences discipline
• 10+ years of experience in the Medical Devices, Biotech, or Diagnostics industry.
• Prior exposure to IVDs/CDx is a desirable
• Managed regulatory teams through successful submissions for global organizations.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Seeking a Quality Assurance Supervisor for a rapidly growing medical and non-medical sustainable manufacturing company. Overseeing the quality assurance team, responsible for training staff, developing policies and monitoring the effects of the quality management.
 

• Full time position, onsite in Ohio
• 7+ years of qualify assurance experience within medical/medical device manufacturing
• 3+ years people management QA upwards of 10 people
• Sound knowledge of Microsoft Suite, particularly excel 
• Very good communication, writing skills and presentations skills,  
• Ability to interact with senior management 

A newly created opportunity to join an excelling immuno-oncology biopharma who have recently posted great financial figures and are creating a lot of excitement around their unique product pipeline. They're looking for an experienced (Associate Director+) project management professional to join their dynamic and growing PMO.

They've got huge partnership deals with big pharma and are making a huge splash and offer a steady career progression trajectory for talented individuals.

Main Responsibilities
 

• Join the PMO at an early stage and use previous experience in providing valuable information in defining strategies and processes.
• Manage project information for assigned projects and is responsible for developing and maintaining good relationships with other functions such that it will foster positive interactions and ultimately support achieving desired project outcomes.
• Responsible for ensuring smooth transitions between action points from initiating IND through product launch and full life cycle management, from early to late stage development.
• Works with the Project Teams and relevant functional areas to lead the development project strategies and project plan (inclusive of timelines, milestones, interdependencies, issues, risks and actions).

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Are you a meticulous and driven quality professional with experience in the medical device industry? We are seeking a Manufacturing Quality Engineer to join our team and play a pivotal role in ensuring the highest standards of product quality and regulatory compliance. If you are passionate about contributing to the advancement of medical technology and have a strong background in quality engineering, we invite you to apply.
 

Position Overview:

As a Manufacturing Quality Engineer, you will be a key contributor in providing quality guidance to Operations, Manufacturing, and Supply Chain teams. Your responsibilities will revolve around ensuring the successful transfer of medical products into manufacturing while adhering to regulatory requirements and operational procedures. Additionally, you will support the maintenance of our quality systems to ensure compliance with industry regulations and standards.

Key Responsibilities:

• Review and approve quality records for the release of finished medical devices, ensuring compliance with acceptance requirements.
• Collaborate with operations to conduct process risk management activities, including hazard identification, FMEA, and risk mitigation according to ISO 14971.
• Lead and execute validation activities (IQ, OQ, PQ) for manufacturing processes of medical device products.
• Conduct root cause analysis for non-conformance issues and implement corrective and preventive actions using CAPA procedures.
• Perform external supplier audits based on ISO 13485 or ISO 9001 standards, ensuring adherence to quality agreements.
• Partner with Operations teams to facilitate the smooth transition of design changes into manufacturing.
• Initiate, review, and approve Engineering and Manufacturing Change Orders.
• Support non-conforming root cause analysis and issue resolution within operations.
• Provide data for quality metrics and participate in management review meetings.
• Serve as a Quality Subject Matter Expert (SME) in cross-functional teams.
• Conduct training on procedures and quality-related topics.
• Assist in the qualification of new suppliers and resolution of supplier-related issues.
• Develop and maintain quality systems, including SOPs, work instructions, and forms.
• Collaborate with site leadership to ensure manufacturing quality needs are communicated and prioritized.

Education & Experience:

• Proficiency in ISO 13485:2016 and 21 CFR Part 820 regulations.
• Strong team player with a hands-on approach to establishing and maintaining quality processes.
• Familiarity with CAPA, non-conforming product investigations, change control, and more.
• Proficiency with Microsoft Office Products.
• Minimum of 2 years’ experience in quality engineering within the medical device industry.
• BA/BS degree in science, engineering, or related technical field, or equivalent experience.
• Experience with internal and external audits (FDA, Notified Body, Supplier)
• Familiarity with manufacturing and product design environments preferred.
• Experience in in vitro medical diagnostics industry is a plus.
• Ability to interact with regulatory auditors preferred.

We are working with a leading compounding pharmacy to find a Supervisor/Shift Manager for the Aseptic Filling department and ensure high-quality, safe, and efficient production processes. This role involves overseeing aseptic filling operations, ensuring compliance with GMP and FDA standards, and driving continuous improvement strategies.

Required Experience:

• Bachelor’s degree in Engineering, Life Sciences, or related field; Master’s degree preferred.
• 5+ years in pharmaceutical manufacturing with at least 3 years in a supervisory role in aseptic or sterile operations.
• Experience in supervising aseptic filling operations, GMP/FDA compliance, lean manufacturing, and regulatory audits.

Our client is actively looking for a Validation Manager for their growing team. This is an on-site position supporting an aseptic fill-finish facility.

You should apply if you have: 

• Bachelors degree with 8+ years of validation experience in a GMP environment 
• 3+ years of management experience 
• Strong aseptic manufacturing experience 
• Experience with aseptic processing, sterilization, cleaning process validation, equipment qualification, media fills, depyrogenation etc

Our client is an international bank who are seeking an Appsec engineer with hands on experience securing CI/CD pipelines. 

Our client is seeking a Formulator to join their team. This is a full-time, on-site role based in Clifton, NJ.

You should apply if you have:

• 3+ years of non-sterile formulation experience (capsules, tablets, vitamins, powders)
• Experience with Nutraceuticals