Principal Engineer Device Design and Development Technical Lead

About This Role

Biogen is seeking a qualified candidate for the role of Principal Engineer Technical Lead in the Device Development group. The position will lead the design and development of patientcentric safe reliable and innovative devices. Beginning with continuous research of cuttingedge technology to develop multidisciplinary drug delivery systems to support Biogens drug product pipeline. Effectively and efficiently bring optimized products to market through rigorous science and engineering by leveraging external partnerships in collaboration with internal Human Factors Packaging Manufacturing Engineering Quality Regulatory Affairs and other crossfunctional stakeholders.

This is a hybrid role to be based at our Headquarters in Cambridge MA.

What You Will Do

• Design innovative drug delivery devices and combination products aligned to Biogens drug product pipeline. These products may range from the selection of prefilled syringes to the design of implantable drug delivery systems.
• Identify multiple solutions and recommend a course of action to leadership. Make complex decisions and troubleshoot in ambiguous situations across the department. Create an environment of experimentation and work across disciplines and functions to advance novel drug delivery solutions.
• Optimize design for usability design robustness and manufacturability. Apply technical functional and business knowledge to design experiments and solutions that contribute to Biogens strategic priorities.
• Create experimental plans analyze data and write reports. Develop and promote the use of novel approaches within your area of expertise. Routinely investigate and create innovative solutions hypotheses and methodologies to solve unique and complex problems.
• Assist with project planning including organizing experiments staff and meetings. Engages in publishing internal and external technical documents and presentation of own scientific work as required. Collaborates with external clinical experts and industry to expand business opportunities.
• Develop relationships with other groups. Communicate difficult technical concepts and influence others to appreciate a novel point of view. Present supportive arguments for complex ideas and projects to internal governance bodies and external stakeholders.
• Contribute to the writing of regulatory filings and answer regulatory questions. Participate in facetoface meetings with regulatory agencies. Liaise with third parties such as contract design and manufacturing companies testing labs and other experts.
• Lead technical team and/or crossfunctional project teams.

Who You Are

You are a highly motivated and resultsoriented engineer with extensive handson experience coupled with exceptional interpersonal and communication abilities. You are skilled in influencing stakeholders negotiating effectively and addressing challenges with diplomacy and tact. With proven experience in leading technical and crossfunctional project teams you thrive at defining and executing projects using project management methodologies consistently delivering results that meet customer requirements and expectations.

Qualifications

Required Qualifications:

• Bachelors degree in engineering.
• 10 years experience in medical device design especially drug delivery systems.

• Demonstrated experience in combination products (such as autoinjectors prefilled syringes wearable injectors pen injectors reconstitution devices etc.
• 5 years experience facilitating the interface between the pharmaceutical company and the medical device vendor base. Ability to communicate and direct supplier activities at the management level.

Preferred Qualifications:

• Advanced degree in Biomedical Electrical or Mechanical engineering with 8 years of experience in medical device design (Class II and Class III) preferably including the design of drug infusion pumps catheters and active and passive implantables.
• Proven experience developing and launching a drug combination product through the entire product development lifecycle.
• Deep device design and development knowledge of first principles analysis tolerance analysis FEA DOE Design for Six Sigma (DFSS) Design for Manufacturing (DFM) etc.
• Deep knowledge of the regulatory and compliance requirements of device/combination products design controls and manufacturing in the US EU and other regions. Experience with ISO 13485 ISOk PMA MDD MDR.
• Deep understanding of new product introduction design and development of extruded molded and/or assembled device products as well as testing and modeling methodologies.
• Demonstrated good decisionmaking capability and driving alignment within matrix organization.

Additional Information

The base salary range for this position is $156000$215000. Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.

Regular employees are eligible to receive both shortterm and longterm incentives including cash bonuses and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.

Benefits

In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social wellbeing including but not limited to:

• Medical Dental Vision & Life insurance
• Fitness & Wellness programs including a fitness reimbursement
• Onsite childcare facility in Cambridge MA
• Short and LongTerm Disability insurance
• A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 31
• Up to 12 company paid holidays 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with companymatched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10000 per calendar year
• Employee Resource Groups participation

Additional Information :

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.