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Sr. Quality Mgr/AD of Quality Assurance – Rhode Island

The Sr. Manager/Associate Director of Quality Engineering is responsible for supporting the development and manufacturing of new and modified products, establishment of quality systems for the effective control of these products and resolution of quality and manufacturing problems which arise during manufacturing and providing direction to the core team members.

Job Functions:
Evaluation and approval of new product designs, specifications and product test procedures.
Designing and executing statistical engineering experiments to compare design alternatives, compare product with competitive products and evaluate performance.
Final Design Verification of all new and modified products.
Oversee and/or conduct Design Failure Modes & Effects Analysis for product risk assessment.
Providing the smooth transition of new products to manufacturing through the continuous review of all quality systems, inspection data and product yields.
Developing process and product controls to assure the consistent manufacturing of products to established specifications.
Validating all processes and equipment that may be important to the function of product being manufactured in order to assure reliability, consistency and compliance with FDA Regulations.
Investigating and providing leadership in resolving product quality problems that occur in the manufacturing processes.
Support failure investigation process to identify root cause of product, process, in order to drive continuous improvement as well as corrective and preventive actions.
Mentoring, coaching and development of Quality personnel.

Sr. Quality Engineering Manager
Bachelor of Science in Engineering required.
Minimum of 8 years’ experience in medical device in a product development environment
Associate Director, Quality Engineering

Bachelor of Science in Engineering required.
Minimum of 10 years’ experience in medical device in a product development environment

To apply for this position please see the link “US Openings” in the Right Column.

Sr. / Product Manager – Northern MA – Biotech

As Product Manager, you will guide a team that is charged with a product line contribution as a business unit. This extends from increasing the profitability of existing products to developing new products for the company.

Managing the entire product line life cycle from strategic planning to tactical activities
Create and execute market research plans to identify customer needs and market requirements.
Participate in market research related to product launch planning, branding and segmentation, positioning, market acceptance, etc.
Become a subject matter expert with competing target enrichment methods as well as technological alternatives
Establish marketing plans, pricing strategies, and product positioning
Establish and develop key internal and external relationships, including cross functional teams, field teams and thought leader
Work with the Market Communications Manager on promotional and launch campaign
Responsible for reviewing product data to ensure that the field force is kept up to date on new developments regarding the companies or competitors’ products

• BA or MS degree
• Minimum 5 years’ experience in product management or related experience in the Life Science market
• Demonstrated success defining and launching life science products; diagnostic testing preferred

To apply for this position please see the link “US Openings” in the Right Column.

Principal Project Engineer – North Shore MA

Senior level leader for the design and development of engineering of class III medical device. This position is responsible for leading and delivering on large scale projects.
Provide disposable expertise and technical leadership on the project and execute on program management requirements and deliverables.
Work with product management to carryout VOC investigations.
Collect, analyze, and document user need results; lead brainstorming efforts to identify potential solutions.
Ability to lead cross-functional technical teams to achieve project objectives.
Independent analysis of solutions for product performance and use problems, exhibiting creativity, foresight, innovation, and judgment in anticipating and solving these problems.
Lead design reviews that prevent design errors and ensure design and process development will meet requirements.
Establish and execute the technical development plan, process, and design strategy.
Manage technical and programmatic risk, ensuring effective risk identification, assessment, and mitigation; especially as it applies to biological, sterilization/contamination, and other patient risks.
Effectively communicate activity status, issues, and mitigation plans with key stakeholders.
Manage the successful hand-off the product to in-house or OEM manufacturing teams.

Job Requirements
Bachelors of Science degree in Mechanical or Plastics engineering.
Minimum of 5 years’ experience in the design of complex medical disposable products.
Extensive working knowledge of plastic processing including: injection molding, extruding, solvent and thermal bonding, and other related processing methods.
Experience applying fundamental concepts of mechanical design and statistical analysis.
Demonstrated history of creating concepts and functioning designs for complex plastic mechanism, linkages, and actuators as part of catheter based delivery devices.
Significant 3D modeling experience (Solidworks preferred) with history of utilizing advanced analytical methods such as FEA, mold-flow, and tolerance analyses to mitigate risk during early development phases

To apply for this position please see the link “US Openings” in the Right Column.

“LSS Team News” June 2015

The Life Science Staffing Team is very happy to announce that Margaret Hassman has joined our recruiting team.
Please join us in welcoming Margaret. Margaret@lifesciencestaffing.com

The Life Science Staffing Team would like to congratulate our client in Central Massachusetts in the Medical Device Industry and their new Principal Supplier Quality Engineer!!!

Inspirational Quote
“I haven’t failed. I’ve just found 10,000 ways that won’t work.” - Thomas Edison