Rangam · 5 hours ago
Design Control Engineer III
Andover, MA
Full-time
Onsite
Mid, Senior Level
$77K/yr - $128K/yr
4+ years expRangam is seeking candidates for a Direct Hire role as a Design Control Engineer III with one of the world’s largest pharmaceutical companies. The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle, interacting with cross-functional development teams.
ConsultingInformation TechnologySoftwareStaffing Agency
Hiring Manager
Satnam Singh
Responsibilities
Ensures that combination product development activities are compliant with quality and regulatory standards – both internal and external
Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures
Provide input and support for design validation, including but not limited to human factors engineering assessments
Support the generation of all regulatory submission data and content for assigned device projects
Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply
Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture
Support internal and external audits of the DPDD Quality System
Qualification
Required
BS degree in appropriate Science & Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 6 to 8 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries
OR MS degree in appropriate Science & Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 4 to 6 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries
Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040 and the EU Medical Devices Directive
Working knowledge of EN 62366 and EU Medical Devices Regulation
Capable of working independently with minimal supervision
High level of attention to technical details and accuracy
Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously
Able to work collaboratively in cross functional teams
Excellent communication (e.g. oral, written, presentation) and interpersonal relationship skills
Proficiency in general computer software such as word processing, spreadsheets, presentations
Understand Good Manufacturing Practices (GMP)
Preferred
Knowledge of current US and global Regulations, FDA and ICH guidance, ISO standards for syringes/injectors, luer connectors, and quality system regulations (Part 4) for combination products
Experience in Design Controls for Combinations Products
Device Risk Management expertise
Understand statistical sampling plan and statistical analysis of test results
Familiar with Human Factors Engineering - Usability Engineering
Understand project management methodologies and capable to provide technical leadership for projects
Familiar with device assembling manufacturing process
Ability to perform mathematical calculations and ability to perform complex data analysis
Benefits
Participation in client's Global Performance Plan with a bonus target of 7.5% of the base salary
401(k) plan with client's Matching Contributions
Additional client's Retirement Savings Contribution
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Company
Rangam
Rangam is a global, innovative, Total Talent management firm with the mission of accelerating meaningful employment for everyone! We are a minority-, woman-, and disability-owned firm with over 25 years of experience promoting sustainable and inclusive talent programs within our communities and employers.
501-1000 employees
H1B Sponsorship
Rangam has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (2)
2023 (4)
2022 (5)
2021 (4)
2020 (9)
Funding
Current Stage
Late StageLeadership Team
Nish Parikh
Co-founder & CEO
Hetal Parikh
Co-Founder & President
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