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Sr. Clinical Research Manager – Northern MA

The Sr Clinical Research Manager is responsible for the coordination/management of all clinical trials.

Responsibilities:

  • Serve as primary point of contact for assigned clinical studies.
  • Develop and implement daily clinical research operations to meet company goals and objectives.
  • Work with investigators to ensure optimal compliance and performance to the protocol, regulatory requirements, discrepancy reporting and ethical practice.
  • Manage Clinical Project Managers and/or Clinical Research Associates.
  • Ensure that Clinical Operations department works closely with Medical Affairs, R&D, Manufacturing, Sales, Marketing, Regulatory Affairs in US, as well as overseas Clinical Groups to drive clinical initiatives.
  • Participate in vendor selection, and establish plans for data processing and data review with vendors.
  • Assist in the preparation of clinical summaries for IDEs, 510(k) s, PMAs and related regulatory filings.
  • Oversee internal and external audits.
  • Oversee SOP review for the department and employee training.
  • Maintain knowledge of competitive technologies and be a subject matter expert in all company products.

Qualifications

·Bachelor’s degree in sciences or related medical/scientific field with a minimum 10 years clinical research experience

·Experienced in managing programs with Class III devices.

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.

ESSENTIAL FUNCTIONS:
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

REQUIREMENTS:
• 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.
Responsibilities
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” July 2015

The Life Science Staffing Team would like to congratulate our client in Northern Massachusetts in the Medical Device Industry and their new Manufacturing Project Lead !!

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