-
IT System Engineer
3 days ago
Titan Industries Watertown, United StatesAbout the Company · For over 30 years, InterConnect has been all about IT: As a system house, we support our customers with IT services and our IntelliOnline software simplifies the work of associations and organizations. · What sets us apart: a friendly team, a respectful work a ...
-
Systems Engineer
3 weeks ago
Watershed Informatics Cambridge, United StatesAbout Watershed · Our vision is to become the leading biocomputing platform. The future of biology is in big data analysis, and we are on a mission to accelerate digital drug discovery with the Watershed platform. Watershed enables scientists to conduct all essential analysis - ...
-
Systems Engineer
3 weeks ago
FirstLight Fiber Somerville, United StatesCloud Services Systems Engineer · FirstLight is a premier Managed Service Provider that offers fully managed technology solutions and data center services. · We are expanding our Somerville, MA engineering team and are looking for technology professionals with 5+ years of experie ...
-
Systems Engineer
1 week ago
FirstLight Fiber, Inc Somerville, United StatesJob Description · Job DescriptionCloud Services Systems Engineer · FirstLight is a premier Managed Service Provider that offers fully managed technology solutions and data center services. · We are expanding our Somerville, MA engineering team and are looking for technology prof ...
-
Systems Engineer
3 weeks ago
Harvard University Cambridge, United StatesAdditional Qualifications and SkillsKnowledge of information technology applications, processes, software and equipment. · Highly specialized knowledge of a specific technology. · Demonstrated team performance skills, service mindset approach, and the ability to act as a truste ...
-
Systems Engineer
3 weeks ago
Saxon Global Somerville, United StatesCandidates must have previous expereince working in a scientific domain. Experience with statistical methods and analytical tools (Python or R) · Experience with databases (MySQL) · Experience with deep learning tools and GPU frameworks (especially PyTorch). · Experience with ...
-
System engineer
3 weeks ago
BlueNova Industries Gloster, United StatesYour job profile: · You are responsible for ensuring a coordinated concept including design, evaluation and analysis for the architecture of high-voltage battery systems, taking into account customer requirements. · You are responsible for adhering to the cost framework and man ...
-
Systems Engineer
3 weeks ago
Harvard University Cambridge, United StatesAdditional Qualifications and SkillsKnowledge of information technology applications, processes, software and equipment. · Highly specialized knowledge of a specific technology. · Demonstrated team performance skills, service mindset approach, and the ability to act as a truste ...
-
System Engineer
3 weeks ago
Omega Dynamics Mendon, United StatesAre you ready to join a company that shares your enthusiasm for the internet? Our client, a leading German company with 120 employees, plays a crucial role in ensuring the functionality of the internet. They are currently seeking a System Engineer (m/w/d) to support the developme ...
-
Systems Engineer
1 week ago
CPS Insurance Services Boston, United StatesJob Description · Job DescriptionWe are seeking an experienced and motivated Systems Engineer to join our team in, to develop TT&C and Satellite Mission Planning and Scheduling software systems in support of our mission critical customers. This program provides Mission Management ...
-
System Engineer
1 week ago
Markley Group Boston, United StatesJob Description · Job DescriptionSalary: $130,000 to $150,000 · Overview: · Markley is New England's largest and longest operating multi-tenant, mission-critical telecommunication, and data center with facilities in Boston and Lowell MA. Markley Properties is looking to add a hi ...
-
Eclipse Innovations Beacon Hill, United StatesBeacon Hill is a specialist for plastic components in the fields of pharmaceuticals, diagnostics, and medical technology, located in Bad Oeynhausen. Since 2016, Beacon Hill has been a part of the Italian Stevanato Group, with over 5,000 employees worldwide. · Passion – Spirit – ...
-
Systems Engineer
1 week ago
Palo Alto Networks Boston, United StatesJob Description · Job DescriptionCompany Description · Our Mission · At Palo Alto Networks everything starts and ends with our mission: · Being the cybersecurity partner of choice, protecting our digital way of life. · Our vision is a world where each day is safer and more secure ...
-
Systems Engineer
1 week ago
Palo Alto Networks Boston, United States Full timeCompany Description · This role is remote out of the Boston area in Massachusetts. · Our Mission · At Palo Alto Networks everything starts and ends with our mission: · Being the cybersecurity partner of choice, protecting our digital way of life. · Our vision is a world where ...
-
Systems Engineer
13 hours ago
Palo Alto Networks Boston, United States Full timeCompany Description · Our Mission · At Palo Alto Networks everything starts and ends with our mission: · Being the cybersecurity partner of choice, protecting our digital way of life. · Our vision is a world where each day is safer and more secure than the one before. We are a ...
-
Infinity Systems Newton, United States"Give your career a head start in an international and innovative work environment with ARTS. As a trusted, creative partner, consultant, and companion for HR services, turnkey industrial solutions, and innovative organizational concepts in various high-tech industries, ARTS unde ...
-
Systems Engineer
1 week ago
Palo Alto Networks Boston, United StatesJob Description · Job DescriptionCompany Description · This role is remote out of the Boston area in Massachusetts. · Our Mission · At Palo Alto Networks everything starts and ends with our mission: · Being the cybersecurity partner of choice, protecting our digital way of life. ...
-
Principal Engineer Systems Engineering
1 week ago
Amgen Cambridge, United StatesIn this vital role the Principal Systems Engineer will ensure the success of multi-functional drug delivery and combination product development efforts through their lifecycle from feasibility through commercial manufacture and lifecycle management. Engineer, Systems Engineer, Sy ...
-
System Engineer
3 weeks ago
Advantage Technical Watertown, United StatesSystems Engineer · Position Type: Direct Hire · Position Location: Waltham, MA · Position Salary: $110,000 $125,000 Base (Depending on Experience) · # of Positions: 3 · Responsibilities: · Work in a fast-paced environment, participating on engineering teams designing, testi ...
-
Lead System Engineer
3 weeks ago
Falconsmartit Cambridge, United StatesJob Title: · Lead System Engineer · Location: · Cambridge, MA · Job Type: · Contract · / · Full-time · Job Description · The Lead Systems Engineer will help define, and drive systems engineering strategy across Hospital Patient Monitoring (HPM) solutions and System of Sy ...
Senior Manager, Systems Engineering - Cambridge, MA, United States - Amgen
Description
Career CategoryEngineeringJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.Senior Manager, Systems Engineering - Combination Product DevelopmentLiveWhat you will doLet's do this. Let's change the world. In this vital role you will be the Senior Manager, Systems Engineering (SMSE) in the Combination Product Operations organization.
The Systems Engineering team guides in the identification, development, commercialization and improvement of drug delivery technologies to provide optimal patient experience in administration of Amgen's therapeutic products.
As a leader in the organization, the SMSE will ensure the success of multi-functional drug delivery and combination product development efforts through their lifecycle from feasibility through commercial manufacture.
The SMSE will work in collaboration with commercial and research colleagues in identification of user needs from market insights.The SMSE will lead a team responsible for the creation and management of system requirements, development of system architecture, and integration of subsystems.
This will require ensuring robust system architecture across the interactions, dependencies, and interfaces of subsystems.The SMSE will lead a team responsible for the integration of the system through clinical and market entry.
The successful candidate will have demonstrated strength and success in managing interactions with key collaborators and colleagues from across process development, operations, research and development, and global commercial organizations to ensure accurate capture of the voice of customer and business into user needs.
Role Responsibilities:
Responsible for recruitment, mentoring, supervision, and directed professional development of a team of systems engineers.
Lead development of robust drug delivery systems and integrated development efforts applying best Systems Engineering principles in combination product development cycles.
Lead formal and ad-hoc technical and design reviews for the integrated system.Spearhead system definition in conformance to global regulatory guidance and best engineering methods including User Needs and System Design Inputs.
Responsible for DHF development and clarity of structure across platform, combination product, and vendor structures to ensure quality and visibility.
Owns integration of requirements, risks, and implemented mitigations through downstream design outputs.Drives system verification and validation strategies across platform and brand-specific presentations.
Owns system performance & reliability targets and subsystem allocations.
Provides authorship and expert technical leadership for regulatory filings.
Responsible for recruitment, mentoring, supervision, and directed professional development of more junior engineers.
WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an experienced people manager with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Systems Engineering experience ORMaster's degree and 6 years of Systems Engineering experience ORBachelor's degree and 8 years of Systems Engineering experience ORAssociate's degree and 10 years of Systems Engineering experience ORHigh school diploma / GED and 12 years of Systems Engineering experienceAnd2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
Master's Degree or PhD in Engineering in mechanical, systems, materials, electrical, or biomedical engineering.10+ years of demonstrated success in medical device, drug delivery, or combination product development for clinical and commercial entry.5+ years of demonstrated success leading development of system architecture and design for medical device, drug delivery, or combination products from concept through market entry.
Familiar with the following standards:
US Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); Needle-based Injection Systems (ISO ; Quality Management (ISO 13485); Risk Management (ISO 14971); EU Medical Device requirements (EU MDR 2021); Medical Electrical Equipment (EN Demonstrated product design and development success through product launch in major global regulatory regions.
Successful experience managing multiple projects in a deadline driven environment.Demonstrated strength in controlled development of user needs, market and system requirements, system and process verification and validation strategies, DOE / SPC / Risk Management methods.
Proficiency driving CTQ hierarchical decomposition (flow-down) to subsystems and components.Strong technical communications, both written and oral at different levels of the business.
INCOSE certification or formal Systems Engineering training/certification.
Strong understanding of injection molding, electronics fabrication, system assembly and manufacturing processes.
Working knowledge of aseptic fill finish and controlled manufacturing environments.
Demonstrated success in platform product development with global multi-generation technology plans.
Robust knowledge of Quality Management Policies and Systems, practical experience in configuration management and change control process/requirements – CCB (change control board), CIT (change implementation team) concepts.
Proficient with Production Part Approval Process (PPAP) methodology, documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software.
Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives.ThriveWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear.
Join is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.Salary Range150,855.00 USD - 185,602.
00 USDSummaryLocation:
US - Massachusetts - CambridgeType: Full time
Senior Manager, Systems Engineering professionals in Cambridge
-
Adam Blind
Student at Harvard University
-
Cole Paulin
Electrical Engineering and Computer Science