Scipro Jobs in Usa

Job Summary

The Manufacturing Engineer II supports the design, development, and improvement of manufacturing processes. This role is responsible for creating and maintaining key manufacturing documentation such as PFMEAs, process flow diagrams, manufacturing cell and line layouts, process routers, equipment qualifications, validation protocols, and work instructions. The engineer works cross-functionally to transfer products into production and support ongoing manufacturing operations. This role also helps implement lean manufacturing practices to improve efficiency, quality, and continuous improvement.

Duties and Responsibilities

• Design and develop manufacturing processes, select equipment, create work instructions, perform process validations (IQ/OQ/PQ), and train production staff.
• Develop, validate, and implement automated, semi-automated, and manual assembly and test equipment for disposable product manufacturing, ensuring proper documentation, calibration, and preventive maintenance.
• Participate in FMEA activities to identify and mitigate process risks.
• Collaborate with Design Engineering and Quality teams to ensure products are designed for manufacturability while meeting cost, quality, and performance requirements.
• Work with Quality and R&D to maintain compliance with internal quality systems and regulatory standards including FDA GMP, QSR, and ISO 13485.
• Support pilot production and develop lean manufacturing cells to improve throughput and product quality.
• Assist production teams by ensuring operators are trained, schedules are followed, and production documentation is accurate. Identify opportunities for process improvement.
• Continuously improve manufacturing processes related to safety, quality, lead time, productivity, and cost.
• Investigate manufacturing issues using NCMR and CAPA systems, determine root causes, and implement corrective and preventive actions.

Must Haves

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Mechanical Engineering Technology, or related field required.
• 5+ years of engineering experience
• 3+ years of medical device manufacturing
• Experience with 3D CAD software (SolidWorks preferred; AutoCAD or Pro/Engineer acceptable).
• Understanding of FDA GMP, QSR, and ISO 13485 requirements.

Nice to Haves

• Six Sigma Black Belt certification is a plus.
• Lean Manufacturing certification is a plus.
• Knowledge of electromechanical component and assembly design and fabrication.

SciPro has partnered with an early-stage life sciences startup developing a novel approach expected to significantly increase the sensitivity of liquid biopsy testing. Their proprietary method enables at-home collection of cfDNA through a non-invasive process.

In addition to being faster, easier, safer, and more cost-effective than traditional clinical blood draws, this approach may provide substantially greater cfDNA yield. Potential applications include oncology, maternal & fetal health, transplant monitoring, and other areas of diagnostic and disease monitoring.

Their mission is to enable better diagnostic insights and ultimately improve patient outcomes through enhanced biological sampling.

They are currently hiring for two positions and both roles will play key parts in advancing ongoing scientific programs. These are full-time, onsite laboratory roles suited for entry-level through experienced Ph.D. scientists.

Responsibilities include:

• Designing and conducting experiments
• Preparing research reports
• Collaborating with internal teams, academic core labs, and external partners

Qualifications

• BS, MS or PhD in biology, genetics, or a related field. Industry experience preferred.
• Experience isolating DNA
• PCR experience (ddPCR strongly preferred)
• Experience with NGS and low pass sequencing in particular
• Hands-on laboratory experience and desire to remain hands-on
• Proven ability to contribute to scientific research projects
• Experience troubleshooting and executing cfDNA analysis

Core Competencies

• Accountability and ownership
• Strong laboratory knowledge (DNA, cfDNA, PCR, NGS; ddPCR a plus)
• Sound decision-making
• Adaptability in fast-paced environments
• Problem-solving and analytical thinking

Responsibilities:

• Ensure all design control activities for new and updated products meet company procedures and global regulatory requirements.
• Lead risk management activities, including hazard analysis, FMEAs, and risk documentation.
• Support sterilization and biocompatibility assessments.
• Own and maintain design control documentation.
• Partner with R&D, Regulatory, Manufacturing, and Project Management to ensure quality is built into every stage of product development.
• Maintain accurate test, validation, and risk records and report progress to leadership.
• Support regulatory submissions (e.g., 510(k), CE Mark).
• Lead root cause investigations and corrective actions related to design issues.
• Support complaint investigations, nonconformances, and CAPAs after product launch.
• Conduct DHF audits to ensure phase completion requirements are met.
• Review and approve engineering documents and test reports.
• Identify opportunities to improve product quality, reduce cost, and increase efficiency.

Requirements

• Bachelor’s degree in Engineering or related field.
• 10+ years of quality engineering experience in medical devices, including new product launches.
• Experience with sterilization and biocompatability
• Strong knowledge of design controls, risk management, and medical device regulations (FDA, ISO, IEC).
• Experience with verification & validation (V&V) and FMEAs.
• Strong problem-solving and statistical analysis skills (e.g., Minitab, JMP).
• Detail-oriented with strong documentation skills.
• Quality certifications (CQE, CSQE, Six Sigma) are a plus.