Overview

Using a strong knowledge of mechanical systems and automation, this position will support all aspects of pharmaceutical product development and manufacturing for products throughout their lifecycle. This includes products in early development, those undergoing clinical investigation, and ultimately those approved for commercialization. This position is responsible for design and development activities for new and existing drug/device products to ensure they meet or exceed requirements and can be manufactured with the highest quality. Another key function of this role is to innovate, develop, and automate various laboratory scale fixtures, equipment, and apparatuses to support a range of pharmaceutical development and manufacturing activities. Work cross-functionally across all areas of Product Development, Technical Operations and with other teams to help facilitate innovative and efficient product development activities.

Responsibilities

Responsibilities include, but may not be limited to:

• Plans and executes routine and nonroutine technical assignments (design, testing, analysis, etc.) with accountability for the efficient progression/ completion of these activities.
• Utilize a firm understanding of engineering principles, standard procedures, and regulations related to medical devices and combination products to ensure compliance with design controls, quality systems and regulatory requirements related to product and process.
• Support the product development and manufacturing teams with regard to mechanical/device innovation, development, and troubleshooting for early development, pipeline, and commercial products.
• Identify/evaluate options for local machine shops and laboratory automation vendors to help facilitate product development and testing activities. Establish strong working relationships with these vendors with a focus on innovative tailored integrated solutions and cost effectiveness.
• Support internal Intellectual Property initiatives associated with areas of expertise.
• Support risk management activities as they relate to product and post market surveillance.
• Plan, execute, and work with minimal supervision and independent judgment.

Qualifications

• B.S. degree in Mechanical Engineering or related field with 5 years of experience (or M.S. with 3-5 years of experience) working in a regulated environment.
• Experience with product development activities (combination products or medical device preferred).
• Experience with prototype and fixture design & fabrication (understanding of engineering drawing dimensioning and tolerancing as well as machining/additive manufacturing methods).
• Experience with electromechanical control systems (LabVIEW, Arduino, PuTTy, etc.) preferred.
• Experience with pharmaceutical fill/finish, inspection, material handling, and processing preferred.
• Working knowledge of medical device international standards preferred.
• Experience using CAD Software (SolidWorks preferred) and performing statistical analysis.
• Proficient with Microsoft Word, PowerPoint, Outlook, Excel, and web-based software for various applications.
• Demonstrated success in delivering results on several technical challenges.
• Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Adaptability, Professionalism, Accountability, Project Management, Problem Solving, Communication (Written and Verbal), Organizational, Analytical, Presentation Skills, Leadership Skills, Interpersonal Skills

Working Conditions

• Position may require periodic evening and weekend work, as necessary to fulfill obligations.
• This role is based in Xeris’ Chicago office and requires a minimum of three days per week in the office. On-site requirements may change at management’s discretion.
• Travel may be required at times to Contract Manufacturing Organizations (CMOs) and Contract Service Providers (CSPs) location. Periodic overnight travel may occur for work.
• Travel up to 15%

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.